Cho 2006.
Methods | Design: single centre, quasi‐RCT. Follow‐up: 10 weeks from baseline. | |
Participants | Major inclusion criteria: stage 1‐2 breast cancer; within 2 years after mastectomy; completion of chemotherapy and/or radiotherapy with or without current hormone therapy use N = 55 (E: 28, C: 27) Mean age: E: 48.7 ± 9.1 years, C: 49.6 ± 6.2 years Stage of breast cancer: E: stage 1 (12, 42.9%), stage 2 (16, 57.1%); C: stage 1 (13, 48.2%), stage 2 (14, 51.8%) |
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Interventions | E: Psycho‐ educational (psychological‐based education) + physical (exercise) + psychological (peer support group activity) Psychological‐based education: group format, conducted by specialists (oncology, nurse, surgeon, dietician, and image consultant), 1 session per week of 90 minutes for ten weeks, topics included understanding breast cancer, treatment and complications of breast cancer, and advice about lymphedema prevention and management, nutrition and diet, sexual and daily life, and effective ways to manage relationships and communication. Exercise: group format, 2 sessions per week of 90 minutes for ten weeks, sessions included a warm up, main exercise and cool‐down; home‐based practice, at least twice per week for ten weeks, practiced basic stretching and stretching each part of the body. Peer support group activity: group format, 1 session per week of 60 minutes for ten weeks, involved participants sharing their feelings, conflicts and experiences. C: waiting‐list control. |
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Outcomes | QOL scale developed by the study authors | |
Notes | E: experimental, C: comparison, RCT: randomised control trial. Dropouts or missing data where reported: Of the 65 participants entered into the study, 6 participants from experimental group and 4 from control were excluded from data analysis due to metastasis or did not complete the post‐test. Meta‐analysis was not possible as the QOL scale used was the study authors' own scale. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly assigned into experimental and waiting‐list control group but method of randomisation was not described |
Allocation concealment (selection bias) | Unclear risk | Study did not provide enough information to allow judgment as concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were aware of allocated interventions since they had to go through the interventions. The researcher was involved in intervention administration |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were aware of allocated interventions since they had to go through the interventions. Study did not provide enough information to allow judgment whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition from intervention and control group described with reasons, and attrition balanced between groups (6 from intervention group, 4 from control group). Reasons for attrition: metastasis for 3 participants and refusal to be involved before completing post‐test for 7 participants |
Selective reporting (reporting bias) | Unclear risk | Study protocol was not available. Study did not provide enough information to allow conclusion if all expected outcome measures were reported |
Other bias | High risk | Study design was quasi‐experimental with a non‐equivalent control group. Sampling method not described. Participation rate not provided |