Littman 2012.
Methods | Randomised controlled trial | |
Participants | Overweight or obese women with diagnosed stage 0‐III breast cancer at least 3 months post treatment (with the exception of antihormonal treatment) Recruited via oncologist referrals, advertising, announcements, a website and direct mailings to interested women Mean age 60.6 years N = 63 |
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Interventions | • Viniyoga (yoga postures, breathing techniques, deep relaxation, meditation), 6 months, 1 to 3 times a week for 75 minutes • Wait‐list, no treatment for 6 months |
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Outcomes | Health‐related quality of life (Functional Assessment of Cancer Therapy ‐ General) at week 48 Fatigue (Functional Assessment of Chronic Illness Therapy ‐ Fatigue) at week 48 |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Eligible women were block randomized to the intervention or a waitlist control group on age (three strata: 21–49, 50–69, and 70–75 years), stage (two strata: 0/I and II/III), and BMI (two strata: 24–29.9 and ≥30 kg/m2) to assure comparability in the two groups." |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "[...] due to the pilot nature of the study and limited funding, we were unable to blind assessors to group assignment." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 16% dropout in yoga group and 13% dropout in control group within 12 months; intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | No protocol available but no hint of selective reporting |
Other bias | Low risk | No hint of other bias |