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Citation

Research question

Study design

Sample size and method

Independent variables and measures

Dependent variables and measures

Results

General strengths

General weakness

Overall quality of study

Summary statement practice

1.

To investigate the impact of yoga for cancer patients who have chemotherapy induced peripheral neuropathy (Zhi et al 2021). To evaluate the health-related outcomes (anxiety, depression, fatigue, insomnia) for cancer patients who received yoga as intervention for CIPN compared to those who did not (Zhi et al 2021).

RCT included the three required elements-manipulation of the independent variable, randomization, and control (Zhi et al 2021). Random assignment of participants into EG (receiving yoga) and CG (wait-list control group not receiving yoga) (Zhi et al 2021).

A total of 41 breast and gynecological cancer survivors. RCT of 8 weeks of yoga(n=21), control(n=20) (Zhi et al 2021). Health related quality of life outcomes measured using HADS, BFI and ISI (Zhi et al 2021).

Eligibility(inclusion)criteria: English speaking cancer survivors, age 10 or older, cancer diagnosis-stage I-III breast, ovarian, or endometrial, patients taking pain medication who can maintain throughout the study (Zhi et al 2021). Exclusion criteria-those practicing yoga or receiving physical therapy and with metastatic disease (Zhi et al 2021).

This is the method of cancer patients receiving yoga (the yoga arm-EP practiced daily for 60 minutes for 12 weeks along-side in person group classes twice a week (Zhi et al 2021). The waitlist control arm (CP) did not receive interventions throughout the 12 weeks (Zhi et al 2021). The protocol emphasized on breathing work to regulate the autonomic nervous system and modifiable postures to improve musculoskeletal flexibility, strength, and balance (Zhi et al 2021).

Anxiety, depression (measured by Hospital Anxiety and Depression Scale (HADS)), fatigue and insomnia (measured by Brief Fatigue Inventory (BFI)), Insomnia Severity Index (ISI), and Treatment Expectancy Scale (TES)

Week 8 (yoga arm HADS decreased -1.61(-2.75, -0.46), and control arm -032( -1.38, 075) points in control arm(p=0.099) (Zhi et al 2021). At week 12, HADS anxiety scores Yoga arm decreased -142(-2.57, -0.28) compared to increase of 0.46(-0.60, 1.53) in wait-list control (p=0.017) (Zhi et al 2021). No significant difference in HADS, BFI or ISI scores between yoga and waitlist control (Zhi et al 2021). Baseline TES was significantly higher in yoga than in waitlist control (14.9 vs. 12.7, p=0.019). (Zhi et al 2021). TES was not associated with HADS anxiety reduction and HADS anxiety reduction was not associated with CIPN pain reduction. (Zhi et al 2021). Neither the percentage of patients taking pain medications, nor the number of pain medications was significantly different between the yoga and wait-list control arms throughout the entire study (Zhi et al 2021).

The researchers used probability sampling (random selection) This means greater confidence that the sample is representative of the population being studied rather than biased. The RCT included all the required component: randomization, intervention, CGs and manipulation of the independent variable)

The researchers used small sample (41 participants). This decreases generalizability of the study. Th researchers explained that future clinical trials with larger sample size are needed to confirm the findings

The research study provided the strongest evidence (level II) for a study that tests whether an intervention or treatment affects patient’s outcome. The results were consistent with existing literature finding the effectiveness of yoga in managing cancer and treatment related symptoms.

This is a moderately well-designed and well-conducted RCT that provides level II evidence. The interventions pose minimal risk and seem feasible to implement in larger studies of more heterogenous populations

2.

To investigate the effects of a five-minute mindful breathing three times per day for three months on perceived stress and mindfulness among cancer patients (Ping et al 2021).

Two arm randomized controlled, longitudinal study. (Ping et al 2021). The intervention group or experimental group (EP) consists of participants who adapted five-minutes mindful breathing intervention. (Ping et al 2021). Participants in the control group received standard care with routine health education on coping with cancer treatment provided by the nurses (Ping et al 2021).

Patients with a distress score 4 or higher were randomly assigned to either a control or intervention group using computer-generated random numbers (Ping et al 2021). The sample size was 50 for the intervention group and 50 for the control group (Ping et al 2021). Inclusion criteria: patients diagnosed with stage I-III cancer with a distress score of at least 4 on the NCCN (Ping et al 2021). Distress thermometer who could understand and follow simple instructions (Ping et al 2021). Exclusion criteria: patients with difficulty breathing, cognitive or comprehension issues, or diagnosed with advanced stage cancer (stage IV). (Ping et al 2021). Sample size calculated using G*Power software (Ping et al 2021). Ethical approval was obtained

Method of mindfulness exercise that involves breathing as an object attention, involved three steps -adopt a physical posture, establish a mindfulness anchor, and maintain mindfulness

Perceived stress and Perceived mindfulness (Ping et al 2021). Perceived stress was measured using the 10-item Perceived Stress Scale (PSS-10) (Ping et al 2021). Mindfulness was measured using the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) (Ping et al 2021).

183 were invited to participate. 46 declined for lack of interest, 37 fell in the exclusion criteria (Ping et al 2021). Thus 100 patients were randomly assigned to the control group(n=50) or the intervention group(n=50).83 participants successfully completed the study at baseline T1(Ping et al 2021). The intervention and control groups had no significant in mean perceived stress scores (Ping et al 2021). At T2 there was a significant difference between the control (x=29.02, SD=3.42) and intervention (x=25.55, SD=5.57) groups (Ping et al 2021). There was also significant difference (p=0.02) in mean perceived mindfulness scores at baseline and T2(Ping et al 2021).

Two arm RCT with large sample size (100 participants) after inclusion and exclusion criteria (Ping et al 2021). Sample size was calculated using G-Power software (Ping et al 2021). Instruments used were clearly defined hence increase validity and reliability. The results showed that regular mindful breathing can be more beneficial to patients compared to standard two-hour weekly group sessions guided by a therapist for two months in addition to a one-day retreat with a MBSR or MBCT program (Ping et al 2021)

The recruitment was from a single health center. Inadequate allocation concealment subjected to allocation biases (Ping et al 2021). The exclusion criteria removed patients with advanced stage cancer (Ping et al 2021

The research study provided the strongest evidence (level II) for a study that tests whether an intervention or treatment affects patient’s outcome. The results were consistent with already known literature. The five minutes mindful breathing showed positive effects in reducing stress and improving mindfulness in patients with cancer during treatment (Ping et al 2021)

Notwithstanding the limitations of the study, it is the first to examine the sustainable effects of a five-minute mindful breathing intervention among patients with cancer (Ping et al 2021). The interventions pose minimal risk and seem feasible to implement in larger studies of more heterogenous populations. The study provided evidence in support of five minutes mindful breathing in patients with cancer which can utilized in conjunction with standard health education to patients with cancer

3.

To investigate the efficiency of body-mind -spirit therapy (BMS) intervention and supportive expressive group therapy on emotional suppression and psychological distress in breast cancer patients (Ho et al 2016)

This study utilized 12- month longitudinal randomized controlled design (Ho et al 2016). Participants were recruited from three Hospitals and one cancer center. Age 18 and 65 years were invited (Ho et al 2016).

A total of 157 non-metastatic breast cancer patients were involved in a three arm RCT, assigned to BMS, SEG, or social support control group (Ho et al 2016). Simple Randomization with computer generated random numbers (1:1:1 ratio) and allocation concealment were done to randomize participants into the BMS, SEG, or control group(Ho et al 2016). Inclusion criteria-diagnosis of stages 1 to stage III breast cancer and completion of active treatments(Ho et al 2016). Exclusion criteria-diagnosis of other cancers within the past 10 years, metastasis or recurrence of cancer, major psychiatric illness such as schizophrenia, pregnancy, or the inability to speak or read Chinese (Ho et al 2016). Ethical approval was obtained.

BMS therapy conducted for 2h once a week for 8 weeks, with 8-12 participants per group, nurturing a holistic healthy lifestyle, normalization of traumatic experiences, and resilience in viewing cancer as an opportunity for growth (Ho et al 2016). The SEG therapy which consisted weekly 2-h group sessions, with 8-12 participants per group, for 8 weeks (Ho et al 2016).

Emotional suppression (assessed by 21-item, 4- point Chinese Courtauld Control Scale), Perceived Stress (measured by 10-item, 5-point Chinese Perceived stress scale, and Anxiety and Depression (measured by the 14-item, 4- point Chinese Hospital Anxiety and Depression Scale) (Ho et al 2016).

The 157 participants were randomized into BMS(n=51), SEG (N=49), and control (n=57) group (Ho et al 2016). Participants in the BMS, SEG, and control group attended 7.4, 7.3 and 7.1 sessions, respectfully (Ho et al 2016). None of the three groups displayed significant changes(p>0.05) in anxiety and depression (Ho et al 2016). For emotional suppression, the control group shows no significant change, both BMS and SEG showed a decreasing trend with significant decreases in the first 4 months (Ho et al 2016). Neither the SEG nor the control group showed any significant changes with respect to perceived stress, whereas the BMS group showed significant concave declining trend with significant decreases in the first 4 months (Ho et al 2016). The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample (Ho et al 2016).

Support of validity as a result of longitudinal and randomized design and low 1 year dropout rate (11.5%) (Ho et al 2016). Qualitative feedback from the participants showed perceived benefits including ability to express their feelings, active professional help, and received group support (Ho et al 2016). The control group showed a stable trend in emotional suppression and psychological distress over the one-year period (Ho et al 2016).

Small sample size, low statistical power. Doubts in the representative of the sample due to self-selection bias in the recruitment process (Ho et al 2016). The standard for SEG is 52 weeks but the study adopted 8-week protocol (Ho et al 2016). Self-report measures were subject to a common bias method (Ho et al 2016). Fidelity was not addressed

The present results did not demonstrate overall effectiveness for either BMS or SEG therapy in the present sample (Ho et al 2016). The participants appear to derive only modest benefit with respect to psychological well-being from either intervention

The present study suffers from low statistical power due to its small size and modest treatment method ((Ho et al 2016). Efficacy of the two interventions could be examined in future large-scale studies with adequate statistical power to explain the plausible stress-reduction effect of Body Mind Spirit and the role of SEG in lowering emotional suppression among breast cancer patients (Ho et al 2016).

4.

To investigate the effectiveness of Mind -body medicine and lifestyle modification in supportive cancer care

Prospective observational controlled study which is reported in accordance with the strengthening the Reporting of Observational Studies in Epidemiology statement (Jeitler et al 2021). Outcome measured included health related quality of life (HRQOL), anxiety, and depression (Jeitler et al 2021). All study and data collection were carried out at the day care department (Jeitler et al 2021).

A cohort study design with a waiting group was implemented (Jeitler et al 2021). The study included 86 cancer survivors after screening 186 patients for eligibility (Jeitler et al 2021). 62 allocated to the intervention group and 24 patients to the waiting group (Jeitler et al 2021). Inclusion criteria: between 25 and 75 years with confirm diagnosis of cancer, initialized conventional treatment according to medical guidelines (Jeitler et al 2021). Exclusion criteria: if participants had a terminal tumor disease or if they were participating in another clinical trial (Jeitler et al 2021).

Semi-residential day care course for 7 hours, 1 day per week over a period of 12 weeks continuous with a total of 84 hours of group session treatment (Jeitler et al 2021).

Quality of life and Fatigue (HRQOL) and the functional assessment of chronic illness therapy (FACIT) was used to measure (Jeitler et al 2021). Anxiety and Depression, measured by the Hospital Anxiety and Depression Scale (HADS). Program includes mindfulness-based stress reduction program, lifestyle modification program (Jeitler et al 2021). Gentle yoga, breathing exercise muscle relaxation, social support, nutrition, massages, and hydrotherapy (Jeitler et al 2021).

A total of 86 participants fulfilled all eligibility criteria and were enrolled in the study (Jeitler et al 2021). 62 allocated to intervention group, 24 patients waiting > 4 weeks to the waiting group(control) (Jeitler et al 2021). There was significant increase in QOL with 95% confidence interval, decreased anxiety/ depression, and decreased fatigue symptoms (Jeitler et al 2021). Anxiety levels were higher than depression at baseline and the improvement for anxiety were more pronounced compared to depression (Jeitler et al 2021).

Comparing the intervention group with the waiting group a significant advantage for the mind body intervention can be observed (Jeitler et al 2021). No serious adverse effects were associated with the day care program and was overall accepted by the patients irrespective of the time effort it entailed (Jeitler et al 2021). In this study the European Organization for Research and Treatment of Cancer Quality of life Questionnaire was used for measurement of QOL (Jeitler et al 2021). L

Findings through observational design (Jeitler et al 2021). Introduction of late waiting group through nonrandomized group in this study (Jeitler et al 2021). The use of control group in the form of a waiting group induces nocebo effects (Jeitler et al 2021). Another limitation is the group setting and mixture of patients undergoing chemotherapy, radiotherapy, hormone therapy and operation (Jeitler et al 2021).

Comparing the intervention group and the waiting group a significant advantage for the mind-body intervention can be observed (Jeitler et al 2021). No serious or relevant adverse occurred that could be related to the intervention (Jeitler et al 2021).

The results of the study point to a beneficial and clinically relevant effect of the day care clinic program on QOL, fatigue, and psychosocial well-being. (Jeitler et al 2021). It appears to have a sustainable effect, which has to be proved in randomized trials (Jeitler et al 2021).

5.

To evaluate the effects and implementation of a mindfulness and relaxation app intervention for patients with cancer as well as patients’ adherence to such an intervention (Mikolasek et al 2021)

Mixed method approach (qualitative and quantitative) For quantitative data, we assessed 4 paper-and-pencil questionnaires that were sent to patients with cancer at baseline and at weeks 4, 10, and 20(Mikolasek et al 2021). Qualitative data consisted of semi structured interviews with 5 health professionals (Mikolasek et al 2021). This is an observational feasibility study with patients recruited through the web (Mikolasek et al 2021). Interviews were also conducted with 5 health professionals on their views on the use of the intervention app on standard care (Mikolasek et al 2021).

 A total of 100 patients with cancer (74 female) with a mean age of 53.2 years (SD 11.6) participated in the study, of which 25 patients used the app regularly until week 20(Mikolasek et al 2021)

Patients completed self-reported outcomes (general health, health-related quality of life, anxiety, depression, distress, mindfulness, and fear of progression) at baseline and at weeks 4, 10, and 20(Mikolasek et al 2021). The frequency of app exercise usage was gathered directly through the app to assess the adherence of patients (Mikolasek et al 2021).

All enrolled patients obtained the mindfulness and relaxation app, which was specifically developed for this study and only available for patients participating in the study (Mikolasek et al 2021). The app offered 3 exercises: mindfulness meditation, guided imagery, and progressive muscle relaxation (Mikolasek et al 2021).

Health related Quality of Life (measured by Functional Assessment of Cancer Therapy-General (FACT-G) (Mikolasek et al 2021). Distress (measured by Distress Thermometer) (Mikolasek et al 2021).  Mindfulness (Freiburg Mindfulness Inventory (FMI) (Mikolasek et al 2021).

LMM analyses revealed improvements in anxiety (P=.04), distress (P<.001), fatigue (P=.01), sleep disturbance (P=.02), quality of life (P=.03), and mindfulness (P<.001) over the course of 20 weeks (Mikolasek et al 2021). The interviews revealed that the health professionals perceived the app as a helpful addition to standard care (Mikolasek et al 2021)

 A strength of the study is the collection of objective data in the form of logging the exercise use for each patient over the course of 20 weeks (Mikolasek et al 2021). Another advantage of this study was the use of a mixed methods approach, which is recommended for the development of digital interventions (Mikolasek et al 2021).

A limitation of the study is that we did not have a control group (Mikolasek et al 2021). Therefore, the effectiveness of the app cannot be determined in this study because regression to the mean could have an impact on the improvement of well-being (Mikolasek et al 2021).

LMM analyses revealed improvements in anxiety (P=.04), distress (P<.001), fatigue (P=.01), sleep disturbance (P=.02), quality of life (P=.03), and mindfulness (P<.001) over the course of 20 weeks (Mikolasek et al 2021The results of this observational feasibility study indicate that a mindfulness and relaxation app can be a feasible and an effective way to deliver a self-care intervention for patients with cancer(Mikolasek et al 2021).

The effectiveness and further aspects regarding the implementation of such an mHealth intervention should be investigated in a future randomized controlled trial (Mikolasek et al 2021).