Cramer 2015.
| Methods | Randomised controlled trial | |
| Participants | Women with diagnosed stage I‐III breast cancer with menopausal symptoms who had completed surgical, radiotherapeutic and/or chemotherapeutic treatment Recruited from a Department of Gynecology Certified Breast Center Mean age 49.2 years N = 40 |
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| Interventions | • Traditional Hatha yoga based on the teachings of Sivananda Saraswati (yoga postures, breathing techniques, meditation), 12 weeks, once weekly for 90 minutes • Wait‐list, usual care |
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| Outcomes | Health‐related quality of life (Functional Assessment of Cancer Therapy ‐ Breast) at week 12 and week 24 Depression (Hospital Anxiety and Depression Scale) at week 12 and week 24 Anxiety (Hospital Anxiety and Depression Scale) at week 12 and week 24 Fatigue (Functional Assessment of Chronic Illness Therapy ‐ Fatigue) at week 12 and week 24 Safety (adverse events) at week 12 and week 24 |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "block randomization with randomly varying block lengths, which were stratified by the intake of anti‐oestrogen medication during the study period (2 strata: no intake and intake). The randomization list was created by a biometrician who was not involved in patient recruitment or assessment using the Random Allocation Software." |
| Allocation concealment (selection bias) | Low risk | "The randomization list was password‐secured and no individual other than the biometrician was able to access it." "Sealed, sequentially numbered envelopes containing the treatment assignments. After obtaining written informed consent and baseline assessment, the study physician opened the lowest numbered envelope to reveal that patient’s assignment." |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Participants were not blinded to the allocated intervention." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding of outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | Study protocol registered before patient recruitment. All of the study’s prespecified (primary and secondary) outcomes were reported in the prespecified way. |
| Other bias | Low risk | No hint of other bias |