CHALLENGE-UK: A UK cohort of the CHALLENGE trial
Research type
Research Study
Full title
CHALLENGE-UK: A UK cohort of a Phase III study (CHALLENGE: the Colon Health and Lifelong Exercise Change study) of the impact of a physical activity programme on disease-free survival in patients with high risk Stage II or Stage III colon cancer: A Randomised Controlled trial.
IRAS ID
205879
Contact name
Paula Tighe
Contact email
Sponsor organisation
Queen's University Belfast
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 9 months, 0 days
Research summary
There is compelling data from observational studies that physical activity (PA) is associated with improved outcomes and quality of life in colon cancer survivors but a prospective randomized trial is needed to provide definitive evidence of this.
The CHALLENGE trial is an international trial developed by the Canadian Cancer Trials Group (CCTG), formerly known as the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). CHALLENGE aims to recruit almost 1000 patients to determine whether a 36 month behaviour support and supervised PA programme in patients with high risk Stage II or Stage III colon cancer who have completed routine treatment (with surgery and chemotherapy) will improve 3-year disease-free survival (DFS) in comparison to standard care. The impact on overall survival and patient-reported outcomes relating to quality of life will also be assessed.
Given the number of patients required to robustly demonstrate the effectiveness of this intervention it is both clinically and economically desirable to conduct the study as a multi-national collaboration. A UK cohort of the CHALLENGE trial has therefore been developed with identical study design but with a number of UK-specific aims as follows:
1. To make a significant contribution to the primary endpoint to ensure generalisability of the results to the UK population.
2. To objectively assess fitness and measure compliance with PA goals.
3. To assess the feasibility and acceptability to patients and carers and their treating clinicians of delivering a combined behavioural support and PA programme in the UK setting, including barriers to participating in such a programme.
4. To assess the effect of the PA programmes on Health and Social Service Use and associated costs
5. To assess the impact of colon cancer on work and activities
6. To undertake exploratory correlative biomarker studies.REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0160
Date of REC Opinion
8 Jun 2016
REC opinion
Favourable Opinion