CHALLENGE Trial

Trial Acronym CHALLENGE-UK
Clinical Area Cancer
Description 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
Status Open for recruitment
RECRUITMENT
Recruitment Duration 24 months
Date Opened to Recruitment 9th March 2018
Target Recruitment 160 CHALLENGE-UK (962 being recruited to the global CHALLENGE study).
Recruitment to date Currently we have 33 patients registered and 29 patients randomised to the study.
Date Closed to Recruitment N/A
No. of Sites 4
TRIAL DESIGN
Trial Design A multi-national, multi-centre, randomised phase III interventional study.
Study Aim To make a significant contribution to the main CHALLENGE Trial (to determine if a structured PA intervention can improve survival in patients with high risk Stage II/Stage III colon cancer), to ensure results are generalisable to the UK population and to determine feasibility and cost-effectiveness of delivering, and adherence to, a PA intervention in the UK.
Objective 1: Three year disease-free survival.
“Objective 2: Secondary objectives are to assess:
• The feasibility of delivering the PA intervention in colon cancer survivors in the UK.
• Objective fitness and compliance with the PA programme.
• The acceptability of the PA programme to patients, families and health care professionals in a UK setting.
• Health and Social Service Use and associated costs
• Impact of colon cancer on work and activities”
CHIEF INVESTIGATOR (CI)
Chief Investigator Dr Victoria Coyle
SPONSOR(s) & FUNDER(s)
Sponsors Queen’s University Belfast
Funder Cancer Research UK (Population Research Committee)