Design and implementation of the Exercise for Health trial: A pragmatic exercise intervention for women with breast cancer

Hayes, Sandra, Rye, Sheree, Battistutta, Diana, Yates, Patsy, Pyke, Chris, Bashford, John and 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: 577-585. doi:10.1016/j.cct.2011.03.015


Author Hayes, Sandra
Rye, Sheree
Battistutta, Diana
Yates, Patsy
Pyke, Chris
Bashford, John
Eakin, Elizabeth
Title Design and implementation of the Exercise for Health trial: A pragmatic exercise intervention for women with breast cancer
Formatted title
Design and implementation of the Exercise for Health trial — A pragmatic exercise intervention for women with breast cancer
Journal name Contemporary Clinical Trials   Check publisher's open access policy
ISSN 0197-2456
1551-7144
1559-2030
Publication date 2011-07-01
Year available 2011
Sub-type Article (original research)
DOI 10.1016/j.cct.2011.03.015
Volume 32
Issue 4
Start page 577
End page 585
Total pages 9
Place of publication Philadelphia, PA, U.S.A.
Publisher Elsevier
Language eng
Formatted abstract
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 and max: 0 and 16) and 13 (min and max: 3 and 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.
Keyword Breast cancer
Exercise
Rehabilitation
Randomised controlled trial
Physical activity
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2012 Collection
School of Public Health Publications
School of Medicine Publications
 
Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 14 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 11 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Wed, 12 Oct 2011, 01:42:51 EST by Geraldine Fitzgerald on behalf of Surgery - Mater Hospital