Meneses 2007.
Methods | Design: Single centre, RCT. Follow‐up: 3 and 6 months from baseline. | |
Participants | Major inclusion criteria: stage 0‐2 breast cancer and no evidence of local recurrence and metastatic disease; within one year of diagnosis, had surgery at least 1 month before, received radiotherapy or chemotherapy, may have been on hormonal therapy N = 256 (E: 125, C: 131) Mean age: overall: 54.5 ± 11.6 years, E: not reported, C: not reportedStage of breast cancer: not reported |
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Interventions | E: Psycho‐educational Psycho‐educational: individual format, conducted by an intervention nurse, 3 face‐to‐face education and support sessions of 60‐90 minutes followed by 5 monthly support face‐to face or telephone sessions of 30 minutes over a 6‐month period, topics included fatigue, lymphedema, pain, menopausal symptoms, hot flushes, sleep problems, anxiety and depression, fear of cancer recurrence, uncertainty, sexual function, family and social relationships, work, financial, ways to maintain health, nutrition and healthy diet, adherence to cancer surveillance, and the unique problems and concerns that each individual participant facing, together with an education binder containing the corresponded materials with each education and support session; do homework assignments, read about the topics, listen to audiotaped materials, and try new self‐management tips C: control (attention control) |
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Outcomes | Quality of life: QOL‐BC | |
Notes | C: comparison, E: experimental, RCT: randomised controlled trial, QOL‐BC: Quality of Life‐Breast Cancer. Dropouts or missing data where reported 4 participants from experimental group and 1 from control did not complete the study and were excluded from data analysis. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation performed but method not described |
Allocation concealment (selection bias) | Unclear risk | Study did not provide enough information to allow judgment as concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether personnel were blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants could be aware of allocated interventions since they had to go through the intervention. Study did not provide enough information to allow judgment whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 4 women in intervention group withdrew during first month of participation but reasons NS. 1 participant in control group died from non‐cancer‐related cause during the study |
Selective reporting (reporting bias) | Unclear risk | Study protocol was not available. Study did not provide enough information to allow conclusion if all expected outcome measures were reported |
Other bias | High risk | Sampling bias likely present as non‐probability sampling used. Participation rate was about 77.0% |