Design and implementation of the Exercise for Health trial – a pragmatic exercise intervention for women with breast cancer
Hayes, Sandra C., Rye, Sheree, Battistutta, Diana, Yates, Patsy, Pyke, Chris, Bashford, John, & Eakin, Elizabeth (2011) Design and implementation of the Exercise for Health trial – a pragmatic exercise intervention for women with breast cancer. Contemporary Clinical Trials, 32(4), pp. 577-585.
Background Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise intervention on function, treatment-related side effects and quality of life following breast cancer, compared with usual care. The intervention commenced six weeks post-surgery, and two modes of delivering the same intervention was compared with usual care. The purpose of this paper is to describe the study design, along with outcomes related to recruitment, retention and representativeness, and intervention participation.
Methods: Women newly diagnosed with breast cancer and residing in a major metropolitan city of Queensland, Australia, were eligible to participate. Consenting women were randomised to a face-to-face-delivered exercise group (FtF, n=67), telephone-delivered exercise group (Tel, n=67) or usual care group (UC, n=60) and were assessed pre-intervention (5-weeks post-surgery), mid-intervention (6 months post-surgery) and 10 weeks post-intervention (12 months post-surgery). Each intervention arm entailed 16 sessions with an Exercise Physiologist.
Results: Of 318 potentially eligible women, 63% (n=200) agreed to participate, with a 12-month retention rate of 93%. Participants were similar to the Queensland breast cancer population with respect to disease characteristics, and the randomisation procedure was mostly successful at attaining group balance, with the few minor imbalances observed unlikely to influence intervention effects given balance in other related characteristics. Median participation was 14 (min, max: 0, 16) and 13 (min, max: 3, 16) intervention sessions for the FtF and Tel, respectively, with 68% of those in Tel and 82% in FtF participating in at least 75% of sessions.
Discussion: Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery.
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|Item Type:||Journal Article|
|Keywords:||Breast cancer, Exercise, Rehabilitation, Randomised controlled trial, Physical activity|
|Subjects:||Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700) > Public Health and Health Services not elsewhere classified (111799)|
|Divisions:||Current > QUT Faculties and Divisions > Faculty of Health|
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Nursing
Current > Schools > School of Public Health & Social Work
|Copyright Owner:||Copyright 2011 Elsevier.|
|Copyright Statement:||NOTICE: this is the author’s version of a work that was accepted for publication in [Contemporary Clinical Trials]. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Contemporary Clinical Trials, [VOL 32, ISSUE 4, (2011)] 10.1016/j.cct.2011.03.015|
|Deposited On:||07 Apr 2011 15:23|
|Last Modified:||10 Jul 2012 08:27|
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