A randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol
Open accessAbstract
BACKGROUND: Colorectal cancer survivors may suffer from a range of ongoing psychosocial and physical problems that negatively impact on quality of life. This paper presents the study protocol for a novel telephone-delivered intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors. METHODS/DESIGN: Approximately 350 recently diagnosed colorectal cancer survivors will be recruited through the Queensland Cancer Registry and randomised to the intervention or control condition. The intervention focuses on symptom management, lifestyle and psychosocial support to assist participants to make improvements in lifestyle factors (physical activity, healthy diet, weight management, and smoking cessation) and health outcomes. Participants will receive up to 11 telephone-delivered sessions over a 6 month period from a qualified health professional or 'health coach'. Data collection will occur at baseline (Time 1), post-intervention or six months follow-up (Time 2), and at 12 months follow-up for longer term effects (Time 3). Primary outcome measures will include physical activity, cancer-related fatigue and quality of life. A cost-effective analysis of the costs and outcomes for survivors in the intervention and control conditions will be conducted from the perspective of health care costs to the government. DISCUSSION: The study will provide valuable information about an innovative intervention to improve lifestyle factors and health outcomes for colorectal cancer survivors. TRIAL REGISTRATION: ACTRN12608000399392.
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Currently, there are just two randomized controlled trials that we know of, in which individuals were randomly assigned to receive either the intervention or the "treatment as usual" condition.
“Currently, there are just two randomized controlled that we know of [29, 35], in which individuals were randomly assigned to receive either the intervention or the “treatment as usual” condition.”
From Application of the Nursing Model Based on Acceptance and Commitment Therapy (ACT) in Improving Mental Health and Quality of Life after Colorectal Cancer Drug Chemotherapy (2021) · cites this paper as [29]
The Methods/Design > Study Design section describes a planned RCT that will randomly assign colorectal cancer survivors to intervention or control groups. But this is a protocol, not a report that participants were assigned, and Methods/Design > Study Conditions describes brochures and newsletters for controls rather than identifying the condition as treatment as usual. The paper does not establish that there were just two such trials. (LLM, conf=0.86)
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- Authors
- Hawkes, A. L., Pakenham, K. I., Courneya, K. S., Gollschewski, S., Baade, P., Gordon, L. G., Lynch, B. M., Aitken, J. F., & Chambers, S. K.
- Affiliations
- Queensland University of Technology (AU)
- The University of Queensland (AU)
- University of Alberta (CA)
- Cancer Council Queensland (AU)
- QIMR Berghofer Medical Research Institute (AU)
- Griffith University (AU)
- Corresponding author
- Hawkes, Anna L
- ORCID
- Venue
- BMC Cancer
- Published
- 2009-08-18
- Volume
- 9
- Issue
- 1
- Pages
- 286-286
- ISSN
- 1471-2407 (ISSN-L)
- PMC
- PMC2746814
- OpenAlex
- W1510816772
- Cited by
- 1
- References
- 40
- Citations by year
- 2019: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Cancer (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- QUT ePrints (Queensland University of Technology) (submittedVersion)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- Griffith Research Online (submittedVersion, cc-by)
- Faculty of Health
- Funders
- Australian Government
- Cancer Australia (496002)
- Cancer Council Queensland
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- colorectal cancer survivors, telephone-delivered intervention, lifestyle intervention, health coaching, physical activity, cancer-related fatigue, quality of life, diet, weight management, smoking cessation, psychosocial support, symptom management, cost-effectiveness
- MeSH terms
- Clinical Protocols, Female, Follow-Up Studies, Humans, Life Style, Male, Prospective Studies, Research Design, Colorectal Neoplasms, Survivors
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