Living with prostate cancer: Randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer

Chambers, Suzanne K., Newton, Robert U., Girgis, Afaf, Nielsen, Lisa, Lepore, Stephen, Mihalopoulos, Cathrine, Gardiner, R. A., Galvao, Daniel A. and Occhipinti, Stefano (2011) Living with prostate cancer: Randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer. BMC Cancer, 11 317.1-317.8. doi:10.1186/1471-2407-11-317


Author Chambers, Suzanne K.
Newton, Robert U.
Girgis, Afaf
Nielsen, Lisa
Lepore, Stephen
Mihalopoulos, Cathrine
Gardiner, R. A.
Galvao, Daniel A.
Occhipinti, Stefano
Title Living with prostate cancer: Randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer
Journal name BMC Cancer   Check publisher's open access policy
ISSN 1471-2407
Publication date 2011-07
Sub-type Article (original research)
DOI 10.1186/1471-2407-11-317
Open Access Status DOI
Volume 11
Start page 317.1
End page 317.8
Total pages 8
Place of publication London, England, U.K.
Publisher BioMed Central
Collection year 2012
Language eng
Formatted abstract
Background
Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity.

Methods/design

A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial.

Discussion
This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention.

Trial Registration
ACTRN12611000392965
Keyword Quality-of-Life
External-Beam Radiotherapy
Physical-Activity
Aerobic Exercise
Radical Prostatectomy
Recurrence Rates
Resistance
Survivors
Health
Index
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article number 317, Study Protocol

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2012 Collection
School of Medicine Publications
 
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Citation counts: TR Web of Science Citation Count  Cited 11 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 11 times in Scopus Article | Citations
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