EXACT-MCRPC Version 1.0
Research type
Research Study
Full title
EXercise for Advanced prostate Cancer: a multicomponent feasibility Trial in men with Metastatic Castrate-Resistant Prostate Cancer (EXACT-MCRPC).
IRAS ID
248301
Contact name
Gillian Prue
Contact email
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Research Summary
There is now good evidence to suggest that exercise is an effective therapy in managing the side effects associated with early prostate cancer. However, data for advanced prostate cancer patients remains limited even though it presents a considerable disease burden that has a profound impact on daily living, quality of life and perhaps most importantly longevity.
This study will investigate whether or not men with advanced prostate cancer can take part in a home based exercise program. The program is designed to increase activity over time and may assist in managing the side effects of the disease. Participants with advanced prostate cancer will be recruited from the Northern Ireland Cancer Centre (NICC) in Belfast. Exercise is described as a new therapy and we propose this exercise program will measurably impact quality of life in men with advanced prostate cancer.
The exercise program will consist of 12 weeks of moderate intensity walking and strengthening exercise at home. Home based programs have been successfully tested in cancer populations and can be effectively incorporated into daily living. Participants will receive an exercise booklet which will provide information regarding safe exercise, avoiding injury and overcoming barriers to exercise. The program will build up exercise over time, aiming to achieve recommended physical activity guidelines by week 12. Participants will be asked to attend the NICC on three occasions and they will receive weekly telephone support. Participants will complete quality of life and symptom questionnaires and participate in follow-up interviews regarding their experience of taking part in the program and if exercise has helped in coping with cancer-related symptoms. As this is a feasibility study, we will also ask participants about ways of improving the program and interview men who declined to take part about their reasons for this.
Summary of Results
Twelve-weeks of home-based, moderate intensity, brisk walking and resistance training was safe and feasible for men with advanced prostate cancer. Feasibility was assessed using recruitment, retention and adherence rates, while adverse events were monitored for safety. Functional fitness and measures of health-related quality of life (HRQoL) were captured before and following the intervention and at 3-months follow-up. From 117 patients screened by clinicians, 49 were deemed eligible and approached, with 30 patients providing informed consent (61% recruitment rate). Of those consented, 28 patients completed assessments prior to the intervention, with 24 patients completing the intervention and 22 completing follow-up (retention rate: 86% and 79% respectively). Task completion for functional fitness and HRQoL outcomes was excellent throughout, with no intervention-related adverse events recorded. Self-reported adherence to the overall intervention was 82%. Exercise training decreased body mass (-1.5%) and improved functional fitness (>10%), fatigue and HRQoL (clinically meaningful changes in both).
REC name
HSC REC B
REC reference
18/NI/0108
Date of REC Opinion
1 Aug 2018
REC opinion
Further Information Favourable Opinion