Hayes 2013 Tel.
Methods | RCT, 3 groups Study start and stop dates: recruitment between October 2006 and June 2008 Length of intervention: 8 months Length of follow‐up: 8 weeks after end of the intervention |
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Participants | 194 breast cancer patients, of which 142 underwent adjuvant therapy concurrently with the exercise intervention (unpublished data for these patients used in the analyses of this review) | |
Interventions |
Intervention group 1: 'Hayes 2013Tel' Telephone (n = 50) ‐ incorporating both aerobic and strength‐based exercises Intervention group 2: 'Hayes 2013 FtF' Face to face (n = 51) ‐ incorporating both aerobic and strength‐based exercises Control group (n = 41): usual care |
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Outcomes | Primary outcome:
Secondary outcomes:
Outcomes measured at: 6 months, 12 months |
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Notes | Funding: This research project was supported by the National Breast Cancer Foundation. The research positions of SH and EE are supported via an NBCF Early Career Research Fellowship and an NHMRC Senior Research Fellowship, respectively. Conflict of interest: Authors declare that they have no conflict of interest. Registered at ACTRN: 012606000233527 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Individually computer‐generated non‐blocked |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants All outcomes | High risk | Not done |
Blinding of personnel/care providers All outcomes | High risk | Not reported Comment: probably not done |
Blinding of outcome assessment (detection bias) Fitness outcomes | Low risk | "assessors blinded to group allocation" |
Blinding of outcome assessment (detection bias) All outcomes except fitness outcomes | High risk | All outcomes except outcomes with clinical assessment: self reported items |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out: all participants
All participants: 14/194 (7.2%) Comment: For the 142 participants undergoing adjuvant therapy: More than 20% drop‐out for 3‐min step test (cardiorespiratory fitness) High risk for cardiorespiratory fitness ITT analysis, no imputation of data |
Selective reporting (reporting bias) | Low risk | Registered prospectively |
Group similarity at baseline | High risk | Slight imbalance in numbers, place of treatment (public vs private hospital), and rates of mastectomy between groups following randomisation. Rate of mastectomies higher in telephone group. This group has the biggest difference in QoL |
Adherence | High risk | 25% did not meet the intervention goal at mid‐ or postintervention and did not increase their total physical activity by 30+ min (a priori deemed clinically relevant) between baseline and mid‐ or postintervention |
Contamination | High risk | The Active Australia Survey showed that the usual‐care group was more active (more minutes per week) than the FtF group and as active as the Tel group at 6 months. At 12 months, the usual‐care group was more active than the FtF group and less active than the Tel group |