Peppone 2015.
Methods | Study design: multi‐centre RCT Number randomised: 167; 75 to Yoga intervention, 92 to control Study start: 2007; stop date: 2012 Length of intervention: 4 weeks Length of follow‐up: to end of intervention Country: USA |
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Participants | Age, years (mean SE):
Stage, n (%):
Inclusion criteria: • Enrolled between 2 and 24 months post surgery, chemotherapy, and/or radiation therapy. For the original study, eligible survivors were required to: • Have a confirmed diagnosis of cancer • Have undergone and completed standard treatment for cancer • Have sleep disturbance (indicated by a response ≥ 3 on a clinical symptom inventory using an 11‐point scale anchored by ‘‘0’’ = no sleep disturbance and ‘‘10’’ = worst possible sleep disturbance) • Be able to read English • Be 21 years of age or older • Be able to give written informed consent • Not have maintained a regular personal practice of yoga within the 3 months before enrolling in the study, or be planning to start yoga on their own during the time they are enrolled in the study • Not have a confirmed diagnosis of sleep apnoea • Not be receiving any form of treatment for cancer, with the exception of hormonal or monoclonal antibody therapy • Not have metastatic cancer Exclusion criteria: • Not reported |
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Interventions | 75 participants assigned to exercise intervention:
Adherence: Not reported 92 participants assigned to control:
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Outcomes | Outcomes: Musculoskeletal symptoms assessed via selected extracted questions from the following validated questionnaires:
Numbers of participants assessed:
Adverse events: not reported |
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Notes | Trial registration link: https://clinicaltrials.gov/ct2/show/NCT00397930 Trial authors contacted: Trial authors were contacted for means and SDs for outcomes. However, they did not provide these data. Intention‐to‐treat analysis: yes, no missing data were reported Funding: NCI and the Office of Cancer Complementary and Alternative Medicine |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Group assignment was determined by a computer‐generated random numbers table in blocks of two and an allocation ratio of 1:1". |
Allocation concealment (selection bias) | Unclear risk | Whether allocation was concealed was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from participants. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was not mentioned whether study personnel and outcome assessors were masked or blinded to study interventions. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data were reported; "all data were analysed using the intent‐to‐treat principle". |
Selective reporting (reporting bias) | Low risk | No selective reporting of outcomes is apparent. |
Other bias | High risk | This study consisted of a secondary analysis from the original study; "the original RCT was designed to test the effect of yoga on sleep quality in all cancer survivors. There was no a priori aim in the study to examine the effect of yoga on musculoskeletal symptoms in breast cancer survivors on endocrine therapy". |