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 34 patients registered and 30 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)