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Design and implementation of the Exercise for Health trial - a pragmatic exercise intervention for women with breast cancer.
MedLine Citation:
PMID:  21463707     Owner:  NLM     Status:  Publisher    
BACKGROUND: Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise interventionon 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 (6months post-surgery) and 10weeks post-intervention (12months 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 FtFparticipating 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.
Sandra Hayes; Sheree Rye; Diana Battistutta; Patsy Yates; Chris Pyke; John Bashford; Elizabeth Eakin
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-4-1
Journal Detail:
Title:  Contemporary clinical trials     Volume:  -     ISSN:  1559-2030     ISO Abbreviation:  -     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-4-5     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2010. Published by Elsevier Inc.
School of Public Health, Queensland University of Technology, Victoria Park Road, Kelvin Grove, 4059, Queensland, Australia; Institute of Health and Biomedical Innovation, Queensland University of Technology, Victoria Park Road, Kelvin Grove, 4059, Queensland, Australia.
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