RESEARCH ARTICLE ANALYSIS Written Assignment
Received: 15 January 2019 | Revised: 19 June 2019 | Accepted: 10 July 2019 DOI: 10.1002/nop2.361
R E S E A R C H A R T I C L E
Are patient education and self‐care advantageous for patients
with head and neck cancer? A feasibility study
Anne Söderlund Schaller1 | Elena Dragioti1 | Gunilla M. Liedberg2 |
Britt Larsson1
1 Pain and Rehabilitation Centre and
Department of Medical and Health
Sciences, Linköping University, Linköping,
Sweden
2 Division of Occupational Therapy,
Department of Social and Welfare Studies,
Faculty of Health Sciences, Campus
Norrkoping, Linköping University, Linköping,
Sweden
Correspondence
Anne Söderlund Schaller, Rehabilitation
Medicine, Department of Medicine and
Health Sciences (IMH), University of
Linköping, Linköping SE‐581 85, Sweden.
Email: [email protected]
1 | I NTR O DUCTI O N
1.1 | Background and objectives
Pain prevalence in patients with head and neck cancer (HNC) is
50%–80% and related to tumour, surgery, chemotherapy and ra‐
diotherapy treatment (RT) (van der Molen et al., 2009). Poor pain
management can be due to inadequate pain assessment and lack
of knowledge among caregivers as well as among patients with
cancer (Oldenmenger, Sillevis Smitt, van Dooren, Stoter, & van der
Rijt, 2009). For example, despite severe pain, patients with cancer
only used about half their prescribed medication (Miaskowski et
al., 2001) and patients' beliefs such as fear of addiction, misunder‐
standing about dosages and feelings that it is not possible to treat
the pain adequately can provide barriers to optimal management of
cancer pain (Gunnarsdottir, Donovan, Serlin, Voge, & Ward, 2002;
Ward et al., 1993). Systematic reviews conclude a decrease in pain
intensity for patients with cancer is associated with education about
pain (Bennett, Bagnall, & Jose Closs, 2009; Howell, Harth, Brown,
Bennett, & Boyko, 2017; Jho, Myung, Chang, Kim, & Ko, 2013; Koller,
Miaskowski, De Geest, Opitz, & Spichiger, 2012; Ling, Lui, & So,
2012; Marie, Luckett, Davidson, Lovell, & Lal, 2013). One system‐
atic review concludes positive effects of education for patients with
cancer on depression, anxiety and quality of life (QoL) (Howell et al.,
2017). However, one review found no effect of patient education on
QoL in patients with cancer (Ling et al., 2012). Educational interven‐
tions for sleep disturbance are sparse (Langford, Lee, & Miaskowski,
2012). Self‐care (SC) refers to what patients do on their own to
achieve, maintain and promote optimal health (Denyes, Orem, Bekel,
& SozWiss, 2001) and may decrease pain in several pain conditions
(Du et al., 2011; Oliveira et al., 2012). Pain in patients with HNC has
been reported to be difficult to treat with analgesics (Epstein et al.,
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© 2019 The Authors. Nursing Open published by John Wiley & Sons Ltd.
Nursing Open. 2019;00:1–14. wileyonlinelibrary.com/journal/nop2 | 1
Abstract
Aim: This study evaluates whether patient education and individually self‐care re‐
duces pain and improves QoL, mood and sleep during and after radiotherapy treat‐
ment for patients with head and neck cancer.
Design: A longitudinal, two‐armed feasibility study design was performed.
Methods: Sixty‐four participants with curative intent were included in the study. All
participants answered questions about pain three times a week and completed a sur‐
vey questionnaire about pain, QoL, psychological aspects and barriers towards pain
management at baseline, at 4 weeks and at 10 weeks. Thirty‐four of the participants
attended in two education sessions on pain based on their beliefs about pain and
received individualized self‐care instructions based on their weekly rating of pain.
Result: This study did not find any significant group differences for the pain, QoL,
mood and sleep.
K E Y WO R D S
education, head and neck cancer, pain, psychological symptoms, quality of life, self‐care
2 | SÖDERLUND SCHALLER Et AL.
2010; Ling & Larsson, 2011). Patients with HNC often suffer from
symptoms that negatively affect QoL (Rogers et al., 2016), mood
(Haisfield‐Wolfe et al., 2012) and sleep (Shuman et al., 2010).
The effect of education and SC on pain and other common symp‐
toms in patients with HNC needs to be elucidated. This study evalu‐
ated whether patient education and individually tailored SC reduces
pain intensity and improves QoL, mood and sleep during and after
RT treatment.
We hypothesized that individually tailored patient education and
adapted SC can help reduce pain, maintain QoL, stabilize mood and
improve sleep in patients with HNC during and after RT.
2 | MET HODS
2.1 | Trial design
This two‐armed feasibility study compared patient education on
management of cancer pain in combination with advice on SC. This
trial is registered in ClinicalTrials.gov Identification NCT03089736.
2.2 | Participants
The participants were patients with HNC undergoing RT and re‐
ferred to the Pain and Rehabilitation Centre (PRC) (University
Hospital, Linköping, Sweden) for anticipated pain. It was not possible
to include patients in the present study before the start of RT. The
Swedish law restricts contact to patients before enrolment to the
PRC. The patients were included within 2 weeks after receiving on‐
going RT. The following inclusion criteria were used as follows: able
to read, write and understand Swedish, registered in RT with cura‐
tive intent and 18 years of age or older. In connection with scheduled
RT, verbal and written information about the study was provided to
all available patients by trained research nurses (TRN). After 1 week,
the eligible patients were asked whether they wanted to be included
in the study. Data in this study were collected as short message ser‐
vices (SMS) and at the PRC.
2.3 | Interventions
2.3.1 | Both groups
All participants answered a SMS with seven items on pain intensity
and interference every Monday, Wednesday and Friday during the
10‐study weeks. If the SMS survey showed ≥3 numeric rating scales
step increase on any items, a TRN phoned the patient the same
day (no later than 3 days if a weekend). Based on the SMS scores,
pharmacological treatment was promptly prescribed or adjusted.
If the patient was displeased with the pain relief at the next day's
phone contact with a TRN (or at next scheduled individual weekly
follow‐up if imminent), the pharmacological treatment was adjusted.
Both groups were offered care as usual at the PRC. Thus, they were
encouraged to contact the TRNs by phone and had access to ad‐
vice from the TRNs. The pharmacological treatment was based on
identical principles for both groups and prescribed by the physicians
according to the ward's policies (Appendix S1).
2.3.2 | The intervention group
Two‐tailored Patient Education Sessions
The scientific literature (Koller et al., 2012; Lovell et al., 2014) on patient
education on management of cancer pain was scrutinized. Six essential
education areas were identified: pain and pain physiology, pain medica‐
tion, side effects of medication and prevention of side effects, abuse of
medications and advice on sleep and anxiety. To make it possible to tai‐
lor education interventions for each patient, a procedure to match The
Barriers Questionnaire II (BQ‐II) items to the six educational areas was
undertaken. Thus, the BQ‐II scoring of the items (several items could
be assigned the same education area) coordinated by most of a group
of nurses (10 experienced nurses employed at PRC and the first author
[AS]) to each education area (Table 1) constituted the base for the in‐
dividual tailoring of education. The inter‐rater reliability of the item‐to‐
education coordination process was measured using a two‐way mixed,
consistency, average‐measures intraclass correlation (ICC) to assess the
degree that the 11 coders provided consistency in their ratings of educa‐
tion areas across the 27 items of the BQ‐II. The ICC was .91. A minimum
summed BQ‐II score (Table 1) of the group of items assigned to each ed‐
ucation area decided whether and which education should be delivered.
At week 1 (baseline [BL]), a TRN delivered a PowerPoint pre‐
sentation covering the education areas. This presentation was
labelled education session 1 (ES 1). To ensure that as many cur‐
rent needs as possible were addressed at week 4 (ES 2), the TRN
initiated a structural discussion with the patient on the specific
education areas presented at ES1. If needed, based on the sec‐
ond scoring of BQ‐II 1 week before the ES 2, additional education
areas were presented at ES 2.
Individually tailored self‐care
The scientific literature of SC for patients with cancer was reviewed
(Johnston et al., 2009; Wong et al., 2006; Worthington et al., 2011),
which was supplemented with the first authors and six nurses em‐
ployed at PRC clinical experiences of pain care regarding patients
with HNC. Fourteen SC measures were identified that covered
maintaining well‐being, prevention of symptoms and pain relief of
mouth and throat (Appendix S2). At weekly follow‐ups at the PRC,
adjustments or initiations of SC were suggested depending on
the previous three SMS scores. As the intention was a preventive
approach, SC measurement was systematically selected and sug‐
gested (Table 2) if the score on any of the SMS items was ≥3 (except
≥1 on the item pain interferences on general activities). In addition,
the TRN verbally presented and provided structured and detailed
written information on the recommended SC (Appendix S2).
2.3.3 | The control group
The control group did not receive the individual tailored education
sessions and the systematic adjustments of SC at weekly follow‐up.
| SÖDERLUND SCHALLER Et AL. 3
TA B L E 1 Items of the Barriers Questionnaire II (BQ‐II) and corresponding education area
Items in BQ‐II (number of the item in BQ‐II)
Confusion from pain medicine cannot be controlled (5)
Using pain medicine blocks your ability to know if you have any new pain (7)
If you take pain medicine when you have some pain, then it might not work as well if the pain becomes worse (15)
Pain medicine can keep you from knowing what's going on in your body (16)
If you use pain medicine now, it won't work as well if you need it later (21)
Pain medicine can mask changes in your health (22)
Education area (least aver‐
age score of adjacent items
for the education to be
offered)
Pain and pain physiology
(12)
Drowsiness from pain medicine is difficult to control (3)
Nausea from pain medicine cannot be relieved (10)
Using pain medicine can harm your immune system (13)
Pain medicine makes you say or do embarrassing things (14)
Constipation from pain medicine cannot be relieved (17)
Pain medicine can hurt your immune system (19)
It is easier to put up with pain than with the side effects that come from pain medicine (20)
Side effects and prevention
of side effects (14)
Cancer pain can be relieved (1)
Pain medicine can effectively control cancer pain (8)
Medicine can relieve cancer pain (24)
Advice on anxiety (reverse
score: items 1, 8, 24 [<9])
How satisfied are you with your current sleep (28) Advice on sleep (2)
However, the weekly follow‐up of the control group was consistent
with the usual care at the PRC. That is, if the patient asked for advice
or if it was apparent to a TRN that one or more unstructured SCs
would be beneficial, verbal advice regarding SC that the TRN came
to think of was provided. This was necessary for ethical reasons.
2.4 | Outcomes
2.4.1 | Primary outcomes
Pain intensity and pain interference
The primary outcome measurements included seven items about
pain intensity and pain interference the previous 24 hr reported by
both groups of patients and collected by SMS every Monday,
Wednesday and Friday during the 10‐study weeks.
The University of California San Francisco (UCSF) Oral Cancer
Pain Questionnaire (Connelly & Schmidt, 2004) measures pain ex‐
periences from the oral cavity and consists of eight items scored on
a scale from 0 (no pain)–10 (the most intense pain). In the SMS sur‐
vey, two items from the Oral Cancer Pain Questionnaire were added
on pain intensity in connection with and without speaking, talking
and drinking. The Oral Cancer Pain Questionnaire is valid for pa‐
tients with oral cancer pain (Connelly & Schmidt, 2004; Kolokythas,
Connelly, & Schmidt, 2007).
The Brief Pain Inventory (BPI) measures two targets: the sub‐
jective intensity of pain and how pain interferes with daily activities
(Cleeland & Ryan, 1994). The BPI consists of 12 items: five items
related to pain intensity and seven items related to pain interfer‐
ence on function both rated on a 0 (no interference)–10 (inter feres
completely) scale. In the SMS survey, five items on pain interference
Advice on anxiety (16) Pain medicine weakens the immune system (4)
It is important to be strong by not talking about pain (11)
It is important for the doctor to focus on curing illness and not waste time controlling pain (12)
If doctors have to deal with pain, they won't concentrate on curing the disease (18)
Pain medicine can mask changes in your health (22)
Doctors might find it annoying to be told about pain (25)
Reports of pain could distract a doctor from curing the cancer (26)
If I talk about pain, people will think I'm a complainer (27)
Abuse about medications (6) There is a danger of becoming addicted to pain medicine (2)
Many people with cancer get addicted to pain medicine (9)
Pain medicine is very addictive (23)
When you use pain medicine, your body becomes used to its effects and soon it won't work anymore (6) Pain medication (14)
Using pain medicine blocks your ability to know if you have any new pain (7)
Pain medicine makes you say or do embarrassing things (14)
If you take pain medicine when you have some pain, then it might not work as well if the pain becomes worse (15)
Pain medicine can keep you from knowing what's going on in your body (16)
If you use pain medicine now, it won't work as well if you need it later (21)
Pain medicine can mask changes in your health (22)
4 | SÖDERLUND SCHALLER Et AL.
TA B L E 2 Self‐care measurements recommended at weekly
follow‐up when NRS score ≥3 on any item (≥1 on the item pain
interferences on general activities) of the short message services
(SMS) scores
Pain intensity
When talking, eating and drinking 3–4, 9–11
When not talking, eating or drinking 3–4, 9–11
Pain interference
General activities 1–4
Mood 1–2, 8
Relations with other people 8
Sleep 5–7
Enjoyment of life 1–2, 8
a Number of self‐care refers to numbers in Appendix S2.
from the BPI were included general activities, mood, relations,
sleep and enjoyment of life. The BPI instrument has been validated
for patients with cancer (Cleeland & Ryan, 1994; Kumar, 2011).
For each subscale and item, the average score of the three
weekly scores was calculated.
2.4.2 | Secondary outcomes
A survey questionnaire including seven validated patient‐re‐
ported outcome measurements was used to collect the outcomes.
Answered at BL, at 4 weeks and at 10 weeks, the secondary out‐
comes cover QoL, pain intensity, pain interference, psychological
aspects and barriers towards pain management. A part of the sec‐
ondary outcomes BL data are reported elsewhere (Schaller, Dragioti,
Liedberg, & Larsson, 2017).
Quality of life
The Euro QoL‐5 Dimension Questionnaire (EQ‐5D) assesses health out‐
come and perceived state of health (Brooks, 1996). The questionnaire
comprises five items: mobility, self‐care, usual activities, pain and discom‐
fort, anxiety and depression. Each item has three response scales – no
problems, some problems and extreme problems – and the answers were
coded 1–3. An algorithm developed for EQ‐5 D was used to calculate the
final individual score. The EQ‐5D score has a range from −0.5–1, where
negative values mean low QoL and 1 means no reduction in QoL. The
EQ‐5D scores were determined by applying scores from standard popu‐
lation values (Dolan, 1997). The second part of the EQ‐5D is the Euro
Quality of Life Vertical Visual Analogue Scale (EQ‐VAS), which measures
the respondent's general health on a vertical visual analogue line with
100‐scale steps with the endpoints labelled “Best imaginable health
state” and “Worst imaginable health state” (Fayers & Machin, 2013).
The EQ‐5D, a valid and reliable instrument (Coons, Rao,
Keininger, & Hays, 2000), was selected because it is a generic in‐
strument that can be used for patients with different conditions and
diseases (Fayers & Machin, 2013).
Pain intensity and pain interference
The Brief Pain Inventory (BPI) measures intensity of pain and pain
interference (see description above) (Cleeland & Ryan, 1994). The
scores were summed, and mean values of the items of pain interfer‐
ence and pain intensity items were calculated. The Swedish version
of BPI used in this study has been linguistically validated (Anderson,
2019) but has not yet been psychometrically validated.
Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) assesses anxi‐
ety and depression (Bjelland, Dahl, Haug, & Neckelmann, 2002).
This scale consists of 14 items: seven items are related to anxiety
Abbreviations: M, mean; SD, Standard deviation. a Student t test for continuous variables or chi‐square test for categorical variables.
TA B L E 3 Participant characteristics at
baseline
Self‐care instruction
Items on pain three times weekly by SMS recommendeda
Characteristic; N (%), un‐
less otherwise stated
Total (N = 64)
Intervention
group (N = 34)
Control group
(N = 30)
p‐valuea
Age (years) (M, SD) 65.05 (±10.47) 64.0 (±10.42) 66.3 (±10.57) .38
Women 25 (39.1) 12 (35.3) 13 (43.3) .51
Living situation
Not living alone 42 (65.6) 22 (64.7) 20 (66.7) .86
Living alone 22 (34.4) 12 (35.3) 10 (33.3)
Education
Primary 10 (15.6) 4 (11.8) 6 (20.0) .25
Second upper school/
vocational
28 (43.8) 13 (38.2) 15 (50.0)
College/University 26 (40.6) 17 (50.0) 9 (30.0)
Smoking habits
Non‐smokers 26 (40.6) 15 (44.1) 11 (36.7) .83
Smokers 10 (15.6) 5 (14.7) 5 (16.7)
Ex‐smokers 28 (43.8) 14 (41.2) 14 (46.7)
| SÖDERLUND SCHALLER Et AL. 5
p‐value
Regression coefficients
(95% CI) B Control group (N = 30)
Intervention group
(N = 34) Variables
TA B L E 4 Mean scores (SD) and regression coefficients for primary outcomes by short message services answers
Pain intensity Q1 (0–10) (M, SD)
Overall effect: p = 0.50
1 week (baseline) 1.94 (2.09) 1.80 (2.22) – –
2 weeks 2.11 (1.46) 2.62 (2.31) 0.82 (0.36 to 1.28) .001
3 weeks 2.90 (1.72) 3.63 (2.59) 1.83 (1.11 to 2.56) .000
4 weeks 3.00 (1.77) 3.74 (2.71) 1.99 (1.13 to 2.84) .000
5 weeks 3.13 (1.62) 3.72 (2.80) 1.94 (0.98 to 2.89) .000
6 weeks 3.28 (1.90) 3.73 (2.76) 1.90 (0.95 to 2.84) .000
7 weeks 2.70 (1.95) 3.34 (2.37) 1.38 (0.35 to 2.40) .009
8 weeks 2.21 (1.76) 2.64 (2.61) 0.71 (−0.48 to 1.90) .240
9 weeks 2.04 (1.68) 2.04 (2.26) 0.34 (−0.74 to 1.44) .530
10 weeks 2.23 (1.86) 1.83 (2.03) −0.19 (−1.32 to 0.95) .743
Pain intensity Q2 (0–10) (M, SD)
Overall effect: p = 0.36
1 week (baseline) 1.30 (1.45) 1.33 (1.93) – –
2 weeks 1.52 (1.26) 1.93 (1.94) 0.60 (0.25 to 0.95) .001
3 weeks 2.17 (1.41) 2.95 (2.49) 1.62 (1.06 to 2.19) .000
4 weeks 2.32 (1.56) 3.12 (2.51) 1.87 (1.18 to 2.57) .000
5 weeks 2.39 (1.56) 3.02 (2.56) 1.77 (1.02 to 2.52) .000
6 weeks 2.61 (1.74) 2.96 (2.63) 1.71 (0.93 to 2.48) .000
7 weeks 2.14 (1.81) 2.67 (2.33) 1.25 (0.36 to 2.14) .006
8 weeks 1.88 (1.65) 2.10 (2.28) 0.84 (−0.13 to 1.80) .090
9 weeks 1.62 (1.52) 1.57 (1.98) 0.44 (−0.46 to 1.35) .338
10 weeks 1.74 (1.54) 1.46 (1.67) −0.008 (−0.95 to 0.93) .987
Pain interference Q1 (0–10) (M, SD)
Overall effect: p = 0.83
1 week (baseline) 1.29 (1.41) 1.21 (1.98) – –
2 weeks 1.56 (1.44) 1.64 (2.03) 0.43 (−0.19 to 1.05) .176
3 weeks 2.10 (1.78) 2.26 (2.56) 1.05 (0.24 to 1.86) .011
4 weeks 2.44 (1.83) 2.57 (2.99) 1.42 (0.43 to 2.41) .005
5 weeks 2.60 (2.05) 2.87 (3.05) 1.73 (0.92 to 2.53) .000
6 weeks 2.67 (2.12) 2.52 (2.61) 1.34 (0.50 to 2.18) .002
7 weeks 2.70 (2.46) 2.55 (2.55) 1.26 (0.39 to 2.12) .004
8 weeks 2.28 (2.19) 2.07 (2.38) 0.93 (−0.01 to 1.87) .052
9 weeks 2.13 (2.14) 1.51 (2.13) 0.48 (−0.42 to 1.38) .297
10 weeks 2.19 (2.06) 1.27 (1.78) 0.03 (−0.79 to 0.84) .948
Pain interference Q2 (0–10) (M, SD)
Overall effect: p = 0.73
1 week (baseline) 1.28 (1.31) 1.29 (1.82) – –
2 weeks 1.53 (1.44) 1.72 (2.08) 0.43 (0.16 to 0.70) .002
3 weeks 2.04 (1.73) 2.31 (2.36) 1.02 (0.56 to 1.48) .000
4 weeks 2.09 (1.84) 2.26 (2.59) 1.09 (0.050 to 1.68) .000
5 weeks 2.17 (1.89) 2.38 (2.59) 1.19 (0.46 to 1.91) .001
6 weeks 2.26 (1.95) 2.30 (2.37) 1.11 (0.50 to 1.72) .000
(Continues)
6 | SÖDERLUND SCHALLER Et AL.
Note: Values presented are model estimates of generalized estimating equations models with a random intercept and adjusted for baseline.
Regression coefficients can be interpreted as the time effect for the groups at a certain follow‐up moment compared with baseline. Significant dif‐
ferences are bold. The estimated impact (i.e. overall effect) of treatment reflects the “combined” within‐ and between‐subjects effects and Q = ques‐
tion. Pain intensity: Q1 = with speaking, talking and drinking, Q2 = without speaking, talking and drinking. Pain interference: Q1 = general activities,
Q2 = mood, Q3 = relations, Q4 = sleep, Q5 = enjoyment of life.
Abbreviations: M, mean; SD, standard deviation.
TA B L E 4 (Continued)
Intervention group
Regression coefficients
Variables (N = 34) Control group (N = 30) (95% CI) B p‐value
7 weeks 2.23 (2.08) 2.17 (2.34) 0.95 (0.34 to 1.56) .002
8 weeks 2.00 (1.96) 1.82 (2.15) 0.68 (−0.01 to 1.38) .054
9 weeks 1.72 (1.91) 1.38 (2.03) 0.43 (−0.32 to 1.18) .259
10 weeks 1.67 (1.57) 1.20 (1.86) 0.29 (−0.36 to 0.94) .386
Pain interference Q3 (0–10) (M, SD)
Overall effect: p = 0.58
1 week (baseline) 1.03 (1.21) 1.00 (1.76) – –
2 weeks 1.23 (1.39) 1.43 (2.14) 0.44 (0.90 to 0.80) .014
3 weeks 1.81 (1.65) 2.11 (2.37) 1.12 (0.59 to 1.66) .000
4 weeks 1.86 (1.67) 2.36 (2.70) 1.50 (0.75 to 2.24) .000
5 weeks 2.10 (1.91) 2.38 (2.59) 1.50 (0.75 to 2.26) .000
6 weeks 2.23 (1.98) 2.07 (2.27) 1.24 (0.59 to 1.88) .000
7 weeks 2.16 (2.21) 2.03 (2.24) 1.18 (0.60 to 1.77) .000
8 weeks 1.74 (1.79) 1.77 (2.37) 0.95 (0.21 to 1.69) .012
9 weeks 1.55 (1.64) 1.42 (2.12) 0.87 (0.03 to 1.71) .043
10 weeks 1.54 (1.52) 1.16 (1.83) 0.74 (−0.02 to 1.49) .056
Pain interference Q4 (0–10) (M, SD)
Overall effect: p = 0.25
1 week (baseline) 1.70 (2.09) 1.17 (1.73) – –
2 weeks 1.84 (1.96) 1.88 (2.28) 0.71 (0.24 to 1.18) .003
3 weeks 2.00 (1.97) 2.18 (2.47) 1.01 (0.47 to 1.55) .000
4 weeks 1.92 (2.00) 2.19 (2.66) 1.07 (0.52 to 1.62) .000
5 weeks 1.72 (1.86) 2.44 (2.62) 1.31 (0.68 to 1.94) .000
6 weeks 1.46 (1.59) 2.49 (2.68) 1.44 (0.81 to 2.06) .000
7 weeks 1.46 (1.56) 2.01 (2.24) 0.81 (0.36 to 1.26) .000
8 weeks 1.08 (1.19) 1.70 (2.05) 0.81 (0.23 to 1.40) .007
9 weeks 1.12 (1.23) 1.55 (2.24) 0.84 (0.12 to 1.55) .022
10 weeks 1.07 (1.29) 1.22 (1.03) 0.69 (−0.08 to 1.46) .078
Pain interference Q5 (0–10) (M, SD)
Overall effect: p = 0.52
1 week (baseline) 1.30 (1.72) 1.24 (1.96)
2 weeks 1.39 (1.79) 1.64 (2.36) 0.40 (0.07 to 0.73) .019
3 weeks 1.72 (1.93) 2.17 (2.62) 0.92 (0.46 to 1.39) .000
4 weeks 1.78 (1.95) 2.04 (2.53) 0.95 (0.40 to 1.51 .001
5 weeks 1.87 (2.00) 2.31 (2.67) 1.20 (0.43 to 1.97) .002
6 weeks 1.85 (1.83) 1.92 (2.41) 0.85 (0.27 to 1.44) .004
7 weeks 1.93 (2.06) 1.73 (2.15) 0.60 (0.09 to 1.11) .022
8 weeks 1.74 (1.81) 1.60 (2.19) 0.62 (−0.09 to 1.33) .087
9 weeks 1.51 (1.83) 1.36 (1.03) 0.50 (−0.19 to 1.19) .158
10 weeks 1.36 (1.51) 1.16 (1.72) 0.49 (−0.14 to 1.12) .128
| SÖDERLUND SCHALLER Et AL. 7
Randomized (n = 64)
Assessed for eligibility (n = 119)
Excluded (n = 55)
Not meeting inclusion criteria (n = 16)
Declined to participate (n = 39)
F I G U R E 1 CONSORT flow chart of the
recruitment process
and seven to depression and is rated on a four‐point scale ranging
from 0–3. The scores were summed, and the range for each subscale
is 0–21. Higher scores indicate likelihood of anxiety or depressive
symptoms. A score of 7 or less indicates a non‐case, a score of 8–10
a doubtful case and a score of 11 or more a definite case. HADS, a
valid and reliable instrument (Bjelland et al., 2002; Zigmond & Snaith,
1983), is widely used in clinical practice, pain care and research and
detects anxiety and depressive symptoms in a general setting.
Pain catastrophizing
The Pain Catastrophizing Scale (PCS) measures thoughts or feelings of
catastrophizing in relation to how individuals experience pain (Sullivan,
Bishop, & Pivik, 1995). The questionnaire comprises 13 items, includ‐
ing subscales for rumination, magnification and helplessness. Each
item is scored on a five‐point scale from 0 (not at all)–4 (all the time). In
this study, the total score was used and summed, and mean values of
the items were calculated. The score range is 0–52, with higher scores
indicating a worse situation. The PCS, a valid and reliable instrument
(Osman et al., 2000), is used in clinical settings and research.
Barriers towards pain
The Barriers Questionnaire II (BQ‐II) comprises 27 items on patient‐
reported beliefs on pain and pain management (Gunnarsdottir et al.,
2002; Ward et al., 1993). Each item is measured on a six‐point scale
– 0 (do not agree at all)–5 (agree very much) – with a total score of
0–135 with higher scores indicating higher barriers. Before this study,
BQ‐II was translated into Swedish using a backward–forward proce‐
dure (Appendix S1, text 1). Cronbach's alpha coefficient was .90. The
BQ‐II has been found to have good validity for patient‐related barriers
to pain management in several studies involving patients with cancer
(Gunnarsdottir et al., 2002; Valeberg et al., 2009; Ward et al., 1993).
Current sleep pattern
The Insomnia Severity Index (ISI), a self‐reported questionnaire,
measures insomnia and provides a measure of the severity of sleep
disorders (Bastien, Vallieres, & Morin, 2001). The ISI comprises
seven items, and each item is rated on a scale from 0–4, and the
total score ranges from 0–28. A higher score suggests more severe
insomnia. In this study, one issue about sleep from the ISI was added
at the end of the BQ‐II and reads as follows: How satisfied are you
with your current sleep? The ISI has been found to be a valid and
reliable instrument (Savard, Savard, Simard, & Ivers, 2005) and was
used because sleep disorders are common in patients with pain.
2.5 | Sample size and randomization
The sample size was assessed based on pain intensity (0–10 scale).
With an assumed clinically relevant average difference in four scale
steps (SD 3), an alpha value of .05 and a power of 80%, each group
was calculated to include approximately 30 patients.
Every second patient of eligible patients was assigned to the con‐
trol group (30 patients), and every second patient was assigned to
the intervention group (34 patients).
2.6 | Allocation concealment mechanism
When patients agreed to participate in the study, their personal data
were documented in consecutive order on a list in a confidential data
Allocation
Follow-Up
Analysis
Analysed (n = 34)
Excluded from analysis (n = 0)
Analysed (n = 30)
Excluded from analysis (n = 0)
Lost to follow-up (n = 0)
Discontinued intervention (n = 0)
Lost to follow-up (n = 0)
Discontinued intervention (n = 0)
Allocated to control group (n = 30) Allocated to intervention group (n = 34)
Received allocated intervention (n = 33)
Did not receive allocated intervention (poor
health) (n = 1)
Enrolment
8 | SÖDERLUND SCHALLER Et AL.
10
8
6
4
2
0
Time
10
8
6
4
2
0
Time
F I G U R E 2 Scores of primary pain intensity outcomes by short
message services (SMS) answers and standard deviation (vertical
bars), for the intervention group (N = 34) and the control group
(N = 30). Q1 = with speaking, talking and drinking, Q2 = without
speaking, talking and drinking. Page 27, Figure 3, above the figure:
Q1 = general activities, Q2 = mood, Q3 = relations, Q4 = sleep,
Q5 = enjoyment of life
file. All patients were assigned a code number and were consecu‐
tively distributed to the intervention group or to the control group
– every other patient to the control group and every other to the
intervention group.
The first author generated the distribution sequence, registered
participants and assigned participants to the intervention or control
group.
2.7 | Statistical methods
All the data were analysed using SPSS 23.0 for Windows (IBM Corp.).
All tests were two‐tailed, and statistical significance was defined as
a value of p ≤ .05. The data are presented as median or mean values
with standard deviation (SD) or minimum and maximum values and as
percentages (%). The differences between groups at baseline were
tested by the Student t tests for continuous variables and chi‐square
test for dichotomous variables. For the primary outcomes, first
the average score was calculated for three time points every week
to measure the primary outcomes for 10 weeks. Then, a linear‐re‐
peated‐measures multilevel model (generalized estimating equations
[GEE] continuous variables) was used to determine the effectiveness
of the intervention compared with control conditions over time. The
estimated impact (i.e. overall effect; Table 4) of treatment on the
outcome in the GEE model reflects the “combined” within‐ and be‐
tween‐subjects effects. The results are presented as regression coef‐
ficients (B) with 95% confidence intervals (CI) and can be interpreted
as the time effect for the groups at a certain follow‐up compared with
baseline. In multilevel analysis, missing scores do not need an impu‐
tation strategy, as this analysis is flexible in handling missing data. A
repeated‐measures ANOVA/mixed model (continuous variables) with
Bonferroni post hoc tests was used for the secondary outcomes.
3 | R ES UL TS
A total of 119 patients were eligible, and 64 were selected (i.e., ran‐
domized) (Figure 1). The patients were randomly assigned to either
the control group (30 patients) or the intervention group (34 pa‐
tients). All 64 patients were analysed on an intention‐to‐treat basis.
Excluded patients (N = 55) did not meet the inclusion criteria (N = 16)
or declined to participate (N = 39). The process of inclusion was on‐
going between January 2015–December 2016.
The 64 patients were diagnosed with HNC and informed on the
curative intent of RT about 6.0 weeks (median) (min 2–max 711) be‐
fore inclusion in the study.
The patients completed the first survey questionnaire in mean
7.4 days (SD 5.9 days) after the start of RT. Mean age of the par‐
ticipants was 65.1 years (SD 10.5 years), and the mean age of the
non‐participants was 70.3 years (SD 12.8 years). Among the partic‐
ipants, 39 (60.9%) were men; the corresponding figure for the non‐
participants was 31 (66.0%). The only reason reported for denying
participating was poor health. Most participants cohabitated (42;
65.6%), most were former smokers (28; 43.8%), 10 (15.6%) were
current smokers, and 26 (40.6%) had a university degree ( Table 3).
We previously have presented descriptive (and BL) data from most
participants elsewhere (Schaller et al., 2017). Of the 34 patients, 33
(97.0%) in the intervention group completed the interventions. The
reason for withdrawal was poor health.
3.1 | Primary outcomes
We evaluated the effects of the intervention with education and SC
on pain intensity and pain interference based on the SMS answers
by performing repeated‐measures GEE model (Table 4; Figures 2 and
3). Missing values were 2%–3% from week 7 to week 10 with respect
to all primary outcomes. The results showed no overall significant
differences between the control and intervention groups over time.
Intervention group
Control group
Intervention group
Control group
P a in
in te
ns ity
Q 2
P a in
in te
ns ity
Q 1
B a
s e
lin e
( w
e e
k 1
) B
a s
e lin
e (
w e e k
1 )
2 w
e e
k s
2 w
e e k
s
3 w
e e
k s
3 w
e e k
s
4 w
e e
k s
4 w
e e k
s
5 w
e e
k s
5 w
e e k
s
6 w
e e
k s
6 w
e e k
s
7 w
e e
k s
7 w
e e k
s
8 w
e e
k s
8 w
e e k
s
9 w
e e
k s
9 w
e e k
s
1 0
w e
e k s
1
0 w
e e k s
| SÖDERLUND SCHALLER Et AL. 9
P a
in in
te rf
e re
n ce
Q 2
P a in
in te
rf e
re n
ce Q
4
B a
se lin
e (
w e
e k
1 )
2 w
e e
ks
3 w
e e
ks
4 w
e e
ks
5 w
e e
ks
6 w
e e
ks
7 w
e e
ks
8 w
e e
ks
9 w
e e
ks
1 0 w
e e
ks
10
8 Intervention group
10 Intervention group
10 Intervention group
Control group 8
6
6
4 4
2
2
0 0
Control group 8
6
4
2
0
Control group
Time Time Time
10
Intervention group
10 Intervention group
8 Control group 8
6 6
4 4
2 2
Control group
0 0
Time Time
F I G U R E 3 Scores of primary pain interference outcomes by short message services (SMS) answers and standard deviation (vertical bars),
for the intervention group (N = 34) and the control group (N = 30)
As expected, time was associated with the primary outcomes
(Table 4) in both groups. Compared with BL pain intensity, pain inter‐
ference on mood and enjoyment of life were higher for weeks 2–7,
pain interference on general activities was higher for weeks 3–7, and
pain interference on relations with other people and on sleep was
higher weeks 2–9. Student's t tests showed results identical to the
GEE analyses.
3.2 | Secondary outcomes
The effects of intervention with education and SC on the secondary
outcomes were examined using mixed repeated‐measures ANOVA
(Table 5; Figures 4 and 5). The between‐subjects factor consisted of
the two groups (intervention and control), and the within‐subjects
factor was three time points (BL, 4 and 10 weeks).
No statistically significant differences existed between the two
groups except for higher EQ‐VAS at BL (Table 5) and sleep satisfac‐
tion at 10 weeks (Figure 4) in the intervention group.
For both groups, time was associated with the secondary outcomes
(Table 5). Pain intensity and interference were significantly lower at
BL compared with 4 weeks and decreased significantly between 4–
10 weeks. Quality of life (EQ‐VAS) was statistically significantly
higher at BL compared with 4 and 10 weeks. Depressive symptoms
(HAD depression) were statistically significantly lower at BL compared
with 4 weeks. Barriers to pain management (BQ‐II) were significantly
lower at 4 and 10 weeks compared with BL. Student's t tests showed
results identical to the mixed repeated‐measures ANOVA analyses.
4 | D ISC USSI O N
This study did not find any significant group differences for the primary
outcomes or for the secondary outcomes during RT. The only exception
was sleep satisfaction, which was significantly higher in the interven‐
tion group at the end of RT. Although the QoL BL scores were signifi‐
cantly higher in the intervention group at BL, they were decreased to
the similar level as the control group at the weeks 4 and 10. As expected
for both groups, associations with time regarding all outcomes during
the RT were found. To our knowledge, no study on pain education and
SC for patients with HNC during RT has been published.
Our results are partly in line with previous RCTs on tailored pain
education and SC during treatment including, for example, RT for
patients with various cancer diseases that did not find any differ‐
ences in pain intensity (Kravitz et al., 2011). The authors of a review
on education and SC (Koller et al., 2012) conclude no improvements
for outpatients, a finding that agrees with our study comprised en‐
tirely of outpatients. One review concluded, however, that patients
with cancer reduced their pain after education and SC (Bennett et
P a in
in te
rf e
re n
ce Q
3
P a
in in
te rf
e re
n ce
Q 1
B a
se lin
e (
w e
e k
1 )
2 w
e e
ks
3 w
e e
ks
4 w
e e
ks
B a
se lin
e (
w e
e k
1 )
2 w
e e
ks
3 w
e e
ks
4 w
e e
ks
5 w
e e
ks
6 w
e e
ks
7 w
e e
ks
8 w
e e
ks
9 w
e e
ks
1 0 w
e e
ks
5 w
e e
ks
6 w
e e
ks
7 w
e e
ks
8 w
e e
ks
9 w
e e
ks
1 0
w e e
ks
B a
se lin
e (
w e
e k
1 )
2 w
e e
ks
3 w
e e
ks
4 w
e e
ks
5 w
e e
ks
6 w
e e
ks
7 w
e e
ks
8 w
e e
ks
9 w
e e
ks
1 0 w
e e
ks
B a
se lin
e (
w e
e k
1 )
2
w e e
ks
3 w
e e
ks
4 w
e e
ks
5 w
e e
ks
6 w
e e
ks
7 w
e e
ks
8 w
e e
ks
9 w
e e
ks
P a
in in
te rf
e re
n ce
Q 5
1 0
w e e
ks
TA B L E 5 Secondary outcomes results from baseline, 4 and 10 weeks and comparisons between‐ and within‐subjects effects (ANOVA)
Baseline mean (SD) 4 weeks, mean (SD) 10 weeks, mean (SD)
p‐value p‐value p‐value p‐value
Intervention Control (be‐ Intervention Control (be‐ Intervention Control (be‐ (within‐sub‐
group group tween group group tween group group tween jects effect Significant post hoc
Variables (N = 34) (N = 30) groups) (N = 34) (N = 30) groups) (N = 34) (N = 30) groups) over time) comparisons
EQ‐5D‐index (range 0.85 (0.16) 0.78 (0.27) .20 0.71 (0.20) 0.68 (0.27) .62 0.76 (0.21) 0.73 (0.27) .71 .003 BL versus 4 weeks; p = .003
−1–+1)
Overall effect: p = .57
EQ‐VAS (range 80.74 (14.24) 68.90 .02 68.28 (19.94) 61.88 .24 74.83 (17.92) 72.43 .67 .000 BL versus 4 weeks; p = .000
0–100) (22.34) (21.22) (22.41) BL versus 10 weeks; p = .001
Overall effect: p = .28
BPI‐intensity (range 6.85 (7.94) 8.13 (9.48) .56 13.0 (8.12) 14.27 .64 8.28 (8.63) 8.46 .94 .000 4 weeks versus BL; p = .000
0–50) (11.56) (10.23) 4 weeks versus 10 weeks;
p = .003
Overall effect: p = .93
BPI‐interference 8.26 (9.57) 8.46 .94 14.82 (11.75) 15.96 .78 9.53 (10.85) 12.67 .41 .001 4 weeks versus BL; p = .002
(range 0–70) (11.18) (17.02) (15.83) 4 weeks versus 10 weeks;
p = .037
Overall effect: p = .91
HAD‐anxiety (range 3.79 (3.29)
0–21)
3.63 (3.86) .86 2.97 (2.88) 3.19 (3.85) .80 2.90 (3.23) 2.88 (3.66) .98 .454 NA
Overall effect: p = .59
HAD depression 2.38 (2.34) 3.67 (3.74) .11 3.42 (2.90) 4.28 (3.76) .35 3.55 (3.41) 3.72 (3.34) .85 .008 BL versus 4 weeks; p = .007
(range 0–21)
Overall effect: p = .73
PCS (range 0–52) 8.82 (9.33) 9.34 .83 7.70 (7.76) 9.88 (12.53) .46 9.65 (9.37) 7.20 (9.42) .34 .627 NA (10.38)
Overall effect: p = .74
Sleep pattern (range 2.21 (1.57) 2.15 (1.56) .88 1.42 (1.39) 1.20 (1.44) .56 1.00 (1.37) 2.08 (1.77) .02 .002 BL versus 4 weeks; p = .001
0–4) BL versus 10 weeks; p = .045
BQ‐II (range 0–135) 54.67 (20.45) 48.10
(20.99)
.27 39.33 (20.78) 38.50
(24.47)
.90 38.38
(21.49)
38.26
(28.53)
.99 .000 BL versus 4 weeks; p = .000
BL versus 10 weeks; p = .001
Notes: Significant differences are in bold. The estimated impact (i.e. overall effect) of treatment reflects the “combined” within‐ and between‐subjects effects.
Abbreviations: BL, baseline; BP I, Brief Pain Inventory; BQ‐II, Barrier Questionnaire; EQ‐5D, EuroQoL‐5‐Dimension Questionnaire; EQ‐VAS, Euro Quality of Life Vertical Visual Analogue Scale; HAD, Hospital
Anxiety and Depression Scale; NA, not applicable; PCS, Pain Catastrophizing Scale; SD, standard deviation.
Overall effect: p = .11
Overall effect: p = .56
1 0
|
S Ö
D E R
L U
N D
S C H
A L L E R
E t A
L.
| SÖDERLUND SCHALLER Et AL. 11
Intervention group
Control group
M e
a n P
C S
M e
a n
B Q
-I I
M e
a n
B P
I I n
te rf
e re
n c
e
F I G U R E 4 Scores of secondary
outcomes and standard deviation (vertical
bars), for the intervention group (N = 34)
and the control group (N = 30)
1.0
0.5
0.0
–0.5
Intervention group
Control group
100
80
60
40
20
Intervention group
Control group
–1.0
50
Intervention group
Control group
0
Baseline 4 weeks 10 weeks
Time
40
60
30
40 20
10 20
0
Baseline 4 weeks 10 weeks
Time
0
Baseline 4 weeks 10 weeks
Time
Baseline 4 weeks 10 weeks
Time
30
20
15 20
10
10
5
0
Baseline 4 weeks 10 weeks
Time
Intervention group
4 Control group
3
0
Baseline 4 weeks 10 weeks
Time
80
60
2 40
F I G U R E 5 Scores of secondary
outcomes with and standard deviation
(vertical bars), for the intervention group
(N = 34) and the control group (N = 30)
1
0
Baseline 4 weeks 10 weeks
Time
20
0
Baseline 4 weeks 10 weeks
Time
20
15
Intervention group
Control group
10
5
0
Intervention group
Control group
Baseline 4 weeks
Time
10 weeks
Intervention group
Control group
Intervention group
Control group
M e
a n
H A
D -A
n xi
e ty
M
e a
n E
Q -5
D -i
n d
e x
S
le e
p p
a tt
e rn
M
e a
n B
P I
In te
n s it y
M e
a n
H A
D -D
e p re
s s io
n
M e
a n
E Q
-V A
S
12 | SÖDERLUND SCHALLER Et AL.
al., 2009). Consistent with previous research (Babin et al., 2008;
Bennett et al., 2009; Ling et al., 2012), all patients in our study re‐
ported high QoL, which significantly decreased during RT. This was
also the case for depressive symptoms. The literature is, however,
contradictory regarding the effects of education and SC on depres‐
sive symptoms in patients with cancer (Dodd et al., 2010; Howell et
al., 2017; Krischer, Xu, Meade, & Jacobsen, 2007).
The improvement on sleep satisfaction favouring the intervention
group at week 10 should be treated with caution as the overall results
do not point to significant effects of education and SC, and therefore,
this could represent a random finding. Moreover, sleep satisfaction
was measured using only one item of the ISI despite the fact that this
item was derived from the Swedish version of the ISI, which has good
internal consistency (Dragioti, Wiklund, Alföldi, & Gerdle, 2015). Both
groups had the significantly highest barriers to pain management at
BL. Self‐gathering of knowledge (Wong, 2012) and the weekly follow‐
ups might have been sources of appropriate information and subse‐
quently reduced barriers in both groups. Our results are in line with
a review that concluded that the influence of education on pain man‐
agement barriers is limited (Oldenmenger et al., 2009).
One explanation for the mainly similar outcomes of the groups
might be the amount of attention given. That is, SMS, the weekly fol‐
low‐ups and the survey questionnaire, which included both groups,
might have influenced the relative impact of our interventions.
During the study period, both groups with ongoing cancer treat‐
ment in our study necessarily met regularly with other healthcare
professionals – such as oncologists, radiotherapists and dentists –
who provided advice according to their treatment as usual. This es‐
sential advice together with the interventions of our project might
have been experienced as excessive information to make efficient
use for the patients and thus might have contributed to a maybe rel‐
atively limited impact of our education and SC interventions. In line
with a study of Astrup, Rustøen, Miaskowski, Paul, and Bjordal (2015)
but in contrast to two other studies (Elting, Cooksley, Chambers, &
Garden, 2007; Epstein, Wilkie, Fischer, Kim, & Villines, 2009), the
patients in our study reported relatively low pain intensity. This
might have constituted a floor effect and thus limited effects of our
interventions.
Eight critical core elements of SC education inventions for
patients with cancer have been identified (Howell et al., 2017).
Several of the core elements were closely observed in our study
but some were probably not emphasized enough. Many fac‐
tors serve as barriers and facilitators to SC (Riegel, Jaarsma, &
Strömberg, 2012), and our consideration of these factors may
have been insufficient.
We found a tendency, although not significant, to less pain in‐
tensity in the intervention group when speaking, eating and talking
and when not performing the above‐mentioned activities at approx‐
imately the middle of the study period (Figure 2).
The main limitations include the simple method of randomiza‐
tion, which may lead to poor allocation concealment and the lack of
blindness, which further accounts for a significant risk of confound‐
ing. However, due to the nature of the disease, the blindness in this
study was not possible. The relatively low BL pain intensity may clar‐
ify why no significant differences were found (i.e. small possibility of
improvement) and possibly constitutes an unintended bias related
to denial to participate in the study by patients most affected by
the HNC. One may argue that nurses are not trained in teaching pa‐
tients, although in our study the intervention was structured, the
TRNs were clinically experienced in the field of pain management
for HNC patients and we can assume that our nursing staff was
highly qualified. The interventions were manualized but treatment
fidelity was not assessed, which might have influenced the accuracy
of the delivered interventions (Dragioti, Dimoliatis, Fountoulakis, &
Evangelou, 2015) beyond their “home‐made” nature. Hence, threats
to internal validity may be present.
The strengths of this study include the very low dropout rates,
little missing data and the participants' recruitment from the
ordinary flow of patients at a department specialized in pain
management at a university hospital. The representativeness of
socio‐demographics in our sample was in line with the general
socio‐demographic profile of patients with HNC. Thus, we can infer
that our results have population validity. However, ecological
validity and further generalizability also may be limited due to the
relatively less impaired population.
5 | C O NCLUS IO NS
The study concluded that all included patients felt relatively healthy
during and after RT. The patients generally reported low pain and
good QoL, mood and sleep. However, it was not possible to confirm
that patient education and SC reduced pain intensity or improved
QoL, mood and sleep during and after RT treatment for HNC.
6 | C LI NI CAL IMPLICATIONS AND FUTURE
RESE ARCH
The study's methodology is based on the structure and the con‐
tinuity of the personal meeting between the patient and the car‐
egiver and close reporting of symptoms (i.e. pain, QoL, mood and
sleep). This applies to both the control and intervention groups (i.e.
irrespective of patient education). A secondary effect of the study
method probably encouraged the patient to pay attention to per‐
ceived symptoms and thus give the caregiver the opportunity to ini‐
tiate adequate pain management in time. The study shows that it is
not primarily pain education that the patient needs. Future research
should include the identification of other needs that arise during the
cancer treatment and how to optimize treatment for the patient's
pain management and QoL.
ACKNOWLEDGEMENTS
We thank Anna Peterson and Marie Berggarden for including pa‐
tients in the study and implementing the interventions.
| SÖDERLUND SCHALLER Et AL. 13
AUTHOR CONTRIBUTIONS
ASS and BL: Study conception and study design. ED, BL ASS and
GL: Data analyses and manuscript drafting. All authors discussed the
results, commented on the manuscript in different versions and ap‐
proved the current version of the manuscript.
RESE ARCH E THIC S COMMIT TEE APPROVAL
All procedures performed in studies involving human participants
were in accordance with the ethical standards of the institutional
and/or national research committee. (Medical Ethical Board of
Linköping University diary number 2014/356‐31) and with the 1964
Helsinki declaration and its later amendments or comparable ethi‐
cal standards. Informed consent was obtained from all participants
included in the study.
ORCID
Anne Söderlund Schaller https://orcid.org/0000‐0002‐0380‐3365
Elena Dragioti https://orcid.org/0000‐0001‐9019‐4125
Gunilla M. Liedberg https://orcid.org/0000‐0003‐2980‐2835
Britt Larsson https://orcid.org/0000‐0001‐6924‐9910
REFERENCE S
Anderson, M. (2019). The Brief Pain Inventory. Retrieved from https://
www.mdanderson.org/research/departments‐labs‐institutes/depar
tments‐divisions/symptom‐research/symptom‐assessment‐tools/
brief‐pain‐inventory.html
Astrup, G. L., Rustøen, T., Miaskowski, C., Paul, S. M., & Bjordal, K. (2015).
Changes in and predictors of pain characteristics in patients with
head and neck cancer undergoing radiotherapy. Pain, 156(5), 967–
979. https://doi.org/10.1097/j.pain.0000000000000142
Babin, E., Sigston, E., Hitier, M., Dehesdin, D., Marie, J. P., & Choussy, O.
(2008). Quality of life in head and neck cancers patients: Predictive
factors, functional and psychosocial outcome. European Archives of
Otorhinolaryngology, 265(3), 265–270. https://doi.org/10.1007/
s00405‐007‐0561‐0
Bastien, C . H., Vallieres, A ., & Morin, C . M. (2001). Validation of the
Insomnia Severity Index as an outcome measure for insomnia re‐
search. Sleep Medicine, 2(4), 297–307. https://doi.org/10.1016/
S1389‐9457(00)00065‐4
Bennett, M. I., Bagnall, A . M., & Jose Closs, S. (2009). How effective are
patient‐based educational interventions in the management of can‐
cer pain? Systematic review and meta‐analysis. Pain, 143(3), 192–199.
https://doi.org/10.1016/j.pain.2009.01.016
Bjelland, I., Dahl, A . A., Haug, T. T., & Neckelmann, D. (2002). The validity
of the Hospital Anxiety and Depression Scale. An updated literature
review. Journal of Psychosomatic Research, 52(2), 69–77. https://doi.
org/10.1016/S0022‐3999(01)00296‐3
Brooks, R. (1996). EuroQol: The current state of play. Health Policy, 37(1),
53–72. https://doi.org/10.1016/0168‐8510(96)00822‐6
Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: Global use of the
Brief Pain Inventory. Annals of the Academy of Medicine, Singapore,
23(2), 129–138.
Connelly, S. T., & Schmidt, B. L. (2004). Evaluation of pain in patients with
oral squamous cell carcinoma. Journal of Pain, 5(9), 505–510. https://
doi.org/10.1016/j.jpain.2004.09.002
Coons, S. J., Rao, S., Keininger, D. L., & Hays, R. D. (2000). A comparative
review of generic quality‐of‐life instruments. Pharmacoeconomics,
17(1), 13–35. https://doi.org/10.2165/00019053‐200017010‐00
002
Denyes, M. J., Orem, D. E., Bekel, G., & SozWiss. (2001). Self‐care: A
foundational science. Nursing Science Quarterly, 14(1), 48–54. https://
doi.org/10.1177/089431840101400113
Dodd, M. J., Cho, M. H., Miaskowski, C., Painter, P. L., Paul, S. M., Cooper,
B. A., … Bank, K. A. (2010). A randomized controlled trial of home‐
based exercise for cancer‐related fatigue in women during and after
chemotherapy with or without radiation therapy. Cancer Nursing,
33(4), 245–257. https://doi.org/10.1097/NCC.0b013e3181ddc58c
Dolan, P. (1997). Modeling valuations for EuroQol health states. Medical
Care, 35(11), 1095–1108. https://doi.org/10.1097/00005650‐19971
1000‐00002
Dragioti, E., Dimoliatis, I., Fountoulakis, K. N., & Evangelou, E. (2015). A
systematic appraisal of allegiance effect in randomized controlled
trials of psychotherapy. Annals of General Psychiatry, 14, 25. https://
doi.org/10.1186/s12991‐015‐0063‐1
Dragioti, E., Wiklund, T., Alföldi, P., & Gerdle, B. (2015). The Swedish ver‐
sion of the Insomnia Severity Index: Factor structure analysis and psy‐
chometric properties in chronic pain patients. Scandinavian Journal of
Pain, 9, 22–27. https://doi.org/10.1016/j.sjpain.2015.06.001
Du, S., Yuan, C., Xiao, X., Chu, J., Qiu, Y., & Qian, H. (2011). Self‐manage‐
ment programs for chronic musculoskeletal pain conditions: A sys‐
tematic review and meta‐analysis. Patient Education and Counseling,
85(3), e299–310. https://doi.org/10.1016/j.pec.2011.02.021
Elting, L. S., Cooksley, C . D., Chambers, M. S., & Garden, A. S. (2007).
Risk, outcomes and costs of radiation‐induced oral mucositis among
patients with head‐and‐neck malignancies. International Journal of
Radiation Oncology, Biology, Physics, 68(4), 1110–1120. https://doi.
org/10.1016/j.ijrobp.2007.01.053
Epstein, J. B., Hong, C., Logan, R. M., Barasch, A., Gordon, S. M., Oberlee‐
Edwards, L., … Brennan, M. T. (2010). A systematic review of orofacial
pain in patients receiving cancer therapy. Supportive Care in Cancer,
18(8), 1023–1031. https://doi.org/10.1007/s00520‐010‐0897‐7
Epstein, J. B., Wilkie, D. J., Fischer, D. J., Kim, Y. O., & Villines, D. (2009).
Neuropathic and nociceptive pain in head and neck cancer patients
receiving radiation therapy. Head & Neck Oncology, 1, 26. https://doi.
org/10.1186/1758‐3284‐1‐26
Fayers, P. M., & Machin, D. (2013). Quality of life: The assessment, anal‐
ysis and interpretation of patient‐reported outcomes. West Sussex,
England: John Wiley & Sons, Ltd.
Gunnarsdottir, S., Donovan, H. S., Serlin, R. C ., Voge, C ., & Ward,
S. (2002). Patient‐related barriers to pain management: The
Barriers Questionnaire II (BQ‐II). Pain, 99(3), 385–396. https://doi.
org/10.1016/S0304‐3959(02)00243‐9
Haisfield‐Wolfe, M. E., McGuire, D. B., Soeken, K., Geiger‐Brown, J., De
Forge, B., & Suntharalingam, M. (2012). Prevalence and correlates
of symptoms and uncertainty in illness among head and neck can‐
cer patients receiving definitive radiation with or without chemo‐
therapy. Supportive Care in Cancer, 20(8), 1885–1893. https://doi.
org/10.1007/s00520‐011‐1291‐9
Howell, D., Harth, T., Brown, J., Bennett, C., & Boyko, S. (2017). Self‐man‐
agement education interventions for patients with cancer: A system‐
atic review. Supportive Care in Cancer, 25(4), 1323–1355. https://doi.
org/10.1007/s00520‐016‐3500‐z
Jho, H. J., Myung, S. K., Chang, Y. J., Kim, D. H., & Ko, D. H. (2013). Efficacy
of pain education in cancer patients: A meta‐analysis of randomized
controlled trials. Supportive Care in Cancer, 21(7), 1963–1971. https://
doi.org/10.1007/s00520‐013‐1756‐0
Johnston, B., McGill, M., Milligan, S., McElroy, D., Foster, C ., & Kearney,
N. (2009). Self care and end of life care in advanced cancer: Literature
review. European Journal of Oncology Nursing, 13(5), 386–398. https://
doi.org/10.1016/j.ejon.2009.04.003
14 | SÖDERLUND SCHALLER Et AL.
Koller, A., Miaskowski, C., De Geest, S., Opitz, O., & Spichiger, E. (2012).
A systematic evaluation of content, structure and efficacy of in‐
terventions to improve patients' self‐management of cancer pain.
Journal of Pain and Symptom Management, 44(2), 264–284. https://
doi.org/10.1016/j.jpainsymman.2011.08.015
Kolokythas, A., Connelly, S. T., & Schmidt, B. L. (2007). Validation
of the University of California San Francisco Oral Cancer Pain
Questionnaire. The Journal of Pain, 8(12), 950–953. https://doi.
org/10.1016/j.jpain.2007.06.012
Kravitz, R. L., Tancredi, D. J., Grennan, T., Kalauokalani, D., Street, R. L.,
Slee, C. K., … Franks, P. (2011). Cancer Health Empowerment for
Living without Pain (Ca‐HELP): Effects of a tailored education and
coaching intervention on pain and impairment. Pain, 152(7), 1572–
1582. https://doi.org/10.1016/j.pain.2011.02.047
Krischer, M. M., Xu, P., Meade, C . D., & Jacobsen, P. B. (2007). Self‐ad‐
ministered stress management training in patients undergoing radio‐
therapy. Journal of Clinical Oncology, 25(29), 4657–4662. https://doi.
org/10.1200/jco.2006.09.0126
Kumar, S. P. (2011). Utilization of brief pain inventory as an assess‐
ment tool for pain in patients with cancer: A focused review. Indian
Journal of Palliative Care, 17(2), 108–115. https://doi.
org/10.4103/0973‐1075.84531
Langford, D. J., Lee, K., & Miaskowski, C. (2012). Sleep disturbance in‐
terventions in oncology patients and family caregivers: A compre‐
hensive review and meta‐analysis. Sleep Medicine Reviews, 16(5),
397–414. https://doi.org/10.1016/j.smrv.2011.07.002
Ling, C. C., Lui, L. Y., & So, W. K. (2012). Do educational interventions
improve cancer patients' quality of life and reduce pain intensity?
Quantitative systematic review. Journal of Advanced Nursing, 68(3),
511–520. https://doi.org/10.1111/j.1365‐2648.2011.05841.x
Ling, I. S., & Larsson, B. (2011). Individualized pharmacological treatment
of oral mucositis pain in patients with head and neck cancer receiving
radiotherapy. Supportive Care in Cancer, 19(9), 1343–1350. https://
doi.org/10.1007/s00520‐010‐0955‐1
Lovell, M. R., Luckett, T., Boyle, F. M., Phillips, J., Agar, M., & Davidson,
P. M. (2014). Patient education, coaching and self‐management for
cancer pain. Journal of Clinical Oncology, 32(16), 1712–1720. https://
doi.org/10.1200/JCO.2013.52.4850
Marie, N., Luckett, T., Davidson, P. M., Lovell, M., & Lal, S. (2013). Optimal
patient education for cancer pain: A systematic review and theory‐
based meta‐analysis. Supportive Care in Cancer, 21(12), 3529–3537.
https://doi.org/10.1007/s00520‐013‐1995‐0
Miaskowski, C., Dodd, M. J., West, C., Paul, S. M., Tripathy, D., Koo,
P., & Schumacher, K. (2001). Lack of adherence with the analge‐
sic regimen: A significant barrier to effective cancer pain manage‐
ment. Journal of Clinical Oncology, 19(23), 4275–4279. https://doi.
org/10.1200/jco.2001.19.23.4275
Oldenmenger, W. H., Sillevis Smitt, P. A . E., van Dooren, S., Stoter, G., &
van der Rijt, C. C. D. (2009). A systematic review on barriers hinder‐
ing adequate cancer pain management and interventions to reduce
them: A critical appraisal. European Journal of Cancer, 45(8), 1370–
1380. https://doi.org/10.1016/j.ejca.2009.01.007
Oliveira, V. C., Ferreira, P. H., Maher, C. G., Pinto, R. Z., Refshauge, K. M.,
& Ferreira, M. L. (2012). Effectiveness of self‐management of low
back pain: Systematic review with meta‐analysis. Arthritis Care &
Research, 64(11), 1739–1748. https://doi.org/10.1002/acr.21737
Osman, A., Barrios, F. X., Gutierrez, P. M., Kopper, B. A., Merrifield, T., &
Grittmann, L. (2000). The Pain Catastrophizing Scale: Further
psychometric evaluation with adult samples. Journal of Behavioral
Medicine, 23(4), 351–365.
Riegel, B., Jaarsma, T., & Strömberg, A. (2012). A middle‐range theory of
self‐care of chronic illness. ANS. Advances in Nursing Science, 35(3),
194–204. https://doi.org/10.1097/ANS.0b013e318261b1ba
Rogers, S. N., Heseltine, N., Flexen, J., Winstanley, H. R., Cole‐Hawkins,
H., & Kanatas, A. (2016). Structured review of papers reporting
specific functions in patients with cancer of the head and neck:
2006–2013. British Journal of Oral & Maxillofacial Surgery, 54(6), e45–
e51. https://doi.org/10.1016/j.bjoms.2016.02.012
Savard, M. H., Savard, J., Simard, S., & Ivers, H. (2005). Empirical valida‐
tion of the Insomnia Severity Index in cancer patients. Psycho‐oncol‐
ogy, 14(6), 429–441. https://doi.org/10.1002/pon.860
Schaller, A., Dragioti, E., Liedberg, G. M., & Larsson, B. (2017). Quality
of life during early radiotherapy in patients with head and neck can‐
cer and pain. Journal of Pain Research, 10, 1697–1704. https://doi.
org/10.2147/jpr.s138113
Shuman, A. G., Duffy, S. A., Ronis, D. L., Garetz, S. L., McLean, S. A.,
Fowler, K. E., & Terrell, J. E. (2010). Predictors of poor sleep qual‐
ity among head and neck cancer patients. The Laryngoscope, 120(6),
1166–1172. https://doi.org/10.1002/lary.20924
Sullivan, M. J., Bishop, S. R., & Pivik, J. (1995). The pain catastrophizing
scale: Development and validation. Psychological Assessment, 7(4),
524. https://doi.org/10.1037/1040‐3590.7.4.524
Valeberg, B. T., Hanestad, B. R., Klepstad, P., Miaskowski, C., Moum, T., &
Rustoen, T. (2009). Cancer patients' barriers to pain management and
psychometric properties of the Norwegian version of the Barriers
Questionnaire II. Scandinavian Journal of Caring Sciences, 23(3), 518–
528. https://doi.org/10.1111/j.1471‐6712.2008.00639.x
van der Molen, L., van Rossum, M. A ., Ackerstaff, A . H., Smeele, L. E.,
Rasch, C. R., & Hilgers, F. J. (2009). Pretreatment organ function in
patients with advanced head and neck cancer: Clinical outcome mea‐
sures and patients' views. BMC Ear, Nose and Throat Disorders, 9, 10.
https://doi.org/10.1186/1472‐6815‐9‐10
Ward, S. E., Goldberg, N., Miller‐McCauley, V., Mueller, C ., Nolan, A.,
Pawlik‐Plank, D., … Weissman, D. E. (1993). Patient‐related barriers
to management of cancer pain. Pain, 52(3), 319–324. https://doi.
org/10.1016/0304‐3959(93)90165‐L
Wong, N. C. (2012). Interaction of comparative cancer risk and cancer ef‐
ficacy perceptions on cancer‐related information seeking and scan‐
ning behaviors. Communication Research Reports, 29(3), 193–203.
https://doi.org/10.1080/08824096.2012.684808
Wong, P. C ., Dodd, M. J., Miaskowski, C., Paul, S. M., Bank, K. A., Shiba, G.
H., & Facione, N. (2006). Mucositis pain induced by radiation therapy:
Prevalence, severity and use of self‐care behaviors. Journal of Pain
and Symptom Management, 32(1), 27–37. https://doi.org/10.1016/j.
jpainsymman.2005.12.020
Worthington, H. V., Clarkson, J. E., Bryan, G., Furness, S., Glenny,
A.‐M., Littlewood, A., … Khalid, T. (2011). Interventions for pre‐
venting oral mucositis for patients with cancer receiving treatment.
Cochrane Database of Systematic Reviews, (4), Cd000978. https://doi.
org/10.1002/14651858.CD000978.pub5
Zigmond, A. S., & Snaith, R. P. (1983). The hospital anxiety and depres‐
sion scale. Acta Psychiatrica Scand., 67(6), 361–370. https://doi.
org/10.1111/j.1600‐0447.1983.tb09716.x
SUPPORTING INFORMATION
Additional supporting information may be found online in the
Supporting Information section at the end of the article.
How to cite this article: Söderlund Schaller A, Dragioti E,
Liedberg GM, Larsson B. Are patient education and self‐care
advantageous for patients with head and neck cancer? A
feasibility study. Nursing Open. 2019;00:1–14. https://doi.
org/10.1002/nop2.361