The Women’s wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol

BMC Cancer

Study Protocol

Kathy Wells¹  Sonj Hall²  Leonie Young³  Alexandra L. McCarthy⁴  Patsy Yates⁵  Sarah Balaam⁵  Dian Tjondronegoro⁵  Amanda McGuire⁵  Neil King⁵  Debra Anderson⁶  Charrlotte Seib⁷  Janine Porter-Steele⁸  Mei Krishnasamy⁹  Wei Song^1,10  Kathryn Lee^1,11  Leanne Monterosso^1,12  Jane Turner^1,13  Kate White^1,14 

[1] Breast Cancer Network Australia, Melbourne, Victoria, Australia;Central Queensland University, Brisbane, Queensland, Australia;Choices Cancer Support Program, Wesley Hospital, Brisbane, Queensland, Australia;Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Queensland, Australia;Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia;Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia;Menzies Health Institute Queensland, Griffith University, Menzies Health Institute Queensland, Parklands Drive, 4215, Southport, Queensland, Australia;Menzies Health Institute Queensland, Griffith University, Menzies Health Institute Queensland, Parklands Drive, 4215, Southport, Queensland, Australia;Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia;Menzies Health Institute Queensland, Griffith University, Menzies Health Institute Queensland, Parklands Drive, 4215, Southport, Queensland, Australia;Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia;Choices Cancer Support Program, Wesley Hospital, Brisbane, Queensland, Australia;Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia;Shanghai Ocean University, Shanghai, China;University of California San Francisco, California, USA;University of Notre Dame, Perth, Western Australia, Australia;St John of God Murdoch Hospital, Perth, Western Australia, Australia;University of Queensland, Brisbane, Queensland, Australia;Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia;University of Sydney, Sydney, New South Wales, Australia;Royal Prince Alfred Hospital, Sydney, New South Wales, Australia;

关键词: Cancer;    Women;    health-related quality of life;    Menopausal symptoms;    Modifiable lifestyle factors;   

DOI  :  10.1186/s12885-017-3088-9

 received in 2016-07-01, accepted in 2017-01-25,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundDespite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women’s Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers.MethodsA single-blinded, multi-centre randomized controlled trial recruited a total of 330 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura’s social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 months (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately.DiscussionWomen treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP.Trial registrationThe protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628, July 28, 2014.

【 授权许可】

CC BY   
© The Author(s). 2017