Kiecolt‐Glaser 2014.
Methods | Randomised controlled trial | |
Participants | Women with diagnosed stage 0‐III breast cancer at least 2 months after completion of surgery and adjuvant treatment (except for aromatase inhibitors or tamoxifen) Recruited from clinical research centre Mean age 51.6 years N = 200 |
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Interventions | • Hatha yoga (yoga postures, breathing techniques), 12 weeks, twice a week for 90 minutes • Wait‐list, no treatment |
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Outcomes | Health‐related quality of life (Medical Outcomes Study 36‐item‐short‐form health survey) at week 12 Depression (Center for Epidemiological Studies Depression Scale) at week 12 Fatigue (Multidimensional Fatigue Symptom Inventory‐Short Form) at week 12 Sleep quality (Pittsburgh Sleep Quality Index) at week 12 Safety (adverse events) at week 12 |
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Notes | Duplicate publications separately reported different outcomes of the same trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The data manager stratified participants by cancer stage (0 v I v II and IIIA) as well as radiation therapy received or not, and then used an online randomization program to obtain the block randomization sequence (six per block) for assignment to yoga or control within strata." |
Allocation concealment (selection bias) | Low risk | "The data manager had no participant contact." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were told to not mention their group assignment to study personnel. Personnel were blinded but participants were not. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The data manager had no participant contact." Participants were told to not mention their group assignment to study personnel during their post‐treatment assessments; questionnaires were administered via computer. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4% attrition in yoga group, 10% in control group |
Selective reporting (reporting bias) | Unclear risk | Study protocol registered. Several reported outcome parameters not listed in study protocol. Duplicate publications separately reported different outcomes of the same trial. |
Other bias | Low risk | No hint of other bias |