Fillion 2008.
Methods | Design: single centre, RCT. Follow‐up: post‐experiment and at 3‐months post‐experiment. | |
Participants | Major inclusion criteria non‐metastatic breast cancer; within 2 years after breast cancer treatment N = 87 (E: 44, C: 43) Mean age: E: 53.1 ± 9.7 years, C: 51.8 ± 10.3 years Stage of breast cancer: E: stage 0 (2, 4.5%), stage1 (21, 47.7%), stage 2 (18, 40.9%), stage 3 (3, 6.8%); C: stage 0 (4, 9.3%), stage 1 (17, 39.5%), stage 2 (12, 27.9%), stage 3 (10, 23.3%) |
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Interventions | E: psycho‐ educational + physical (exercise) Psycho‐educational + physical (exercise): group meeting format, one session per week of 2.5 hours for four weeks (1 hour was supervised walking training, 1.5 hours was psycho‐educative fatigue management session), with daily home‐based practice of relaxation and exercise, plus one booster telephone session of 5‐15 minutes between 7th and 8th week after completion of psycho‐educational and exercise interventions. C: usual care. |
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Outcomes | Quality of life: SF‐12 Others: POMS, MFI |
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Notes | C: comparison, E: experimental, MFI: Multidimensional Fatigue Inventory, POMS: Profile of Mood States, SF‐12: Short Form (12) Health Survey. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants randomly assigned to study groups through a sequence of randomisation which was computer‐generated, after a preliminary stratification, according to the adjuvant treatments received |
Allocation concealment (selection bias) | Low risk | A kinesiologist randomly assigned each participant to groups using sealed envelopes, which were concealed to both kinesiologist and patient till then |
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 | Low risk | Attrition from both groups balanced (4 from intervention, 3 from control) with reasons provided. Reasons for withdrawal in intervention group were disease recurrence (2), withdrawal (1) and metastatic disease (1) and withdrawal in control group was due to withdrawal (2) and disease recurrence (1). participants who did not receive allocated intervention were not included in analysis |
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 | Participation rate was 18.9%. Sampling bias likely present as non‐probability sampling was used |