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. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

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
Participants Age, years (mean SE):
  • Intervention: 55.1 (1.24)

  • Control: 53.2 (0.86)


Stage, n (%):
  • Intervention: stage 0‐I, 32 (44.4); stage II, 30 (41.7); stage III, 10 (13.9)

  • Control: stage I, 48 (53.9); stage II 31 (34.8); stage III, 10 (11.2)


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
Interventions 75 participants assigned to exercise intervention:
  • YOCAS (Yoga intervention based on gentle Hatha and restorative yoga) twice a week for 4 weeks. Each session had a duration of 75 minutes and was performed in groups.


Adherence:
Not reported
92 participants assigned to control:
  • Wait‐list standard care control; participants were offered YOCAS training after completing study requirements. During the control period, they received the same attention (as the intervention group) from staff, apart from YOCAS training. Participants were asked not to start a new yoga or exercise regimen on their own during this 4‐week period to avoid exercise contamination.

Outcomes Outcomes:
Musculoskeletal symptoms assessed via selected extracted questions from the following validated questionnaires:
  • University of Rochester Cancer Center Symptom Inventory (URCC SI)

  • FACIT‐F

  • MFSI‐Short Form


Numbers of participants assessed:
  • Intervention: baseline, 72; at 4 weeks, 72

  • Control: baseline, 92; at 4 weeks, 92


Adverse events: not reported
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
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".