Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

Summary

RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.

PURPOSE: This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

Conditions

• Anxiety Disorder
• Cognitive/Functional Effects
• Colorectal Cancer
• Depression
• Fatigue
• Psychosocial Effects of Cancer and Its Treatment
• Sleep Disorders
• Excercise

Interventions

BEHAVIORAL

exercise intervention

3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36

OTHER

counseling intervention

Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.

OTHER

educational intervention

Once at the beginning of the program

OTHER

laboratory biomarker analysis

Every 12 months

OTHER

questionnaire administration

Every 6 months

OTHER

study of socioeconomic and demographic variables

Every 6 months

PROCEDURE

fatigue assessment and management

Every 6 months

PROCEDURE

quality-of-life assessment

Every 6 months

OTHER

Educational Intervention

For Arm 2 just once at beginning of program.

OTHER

Fitness testing

Objective fitness testing for both arms

Sponsors & Collaborators

• Survivorship Research Group

  collaborator UNKNOWN

• Queen's University, Belfast

  collaborator OTHER

• Canadian Cancer Trials Group

  lead NETWORK

Principal Investigators

• Kerry Courneya, PhD · University of Alberta

• Christopher Booth, MD · Cancer Centre of Southeastern Ontario at Kingston General Hospital

• Janette Vardy, PhD, FRACP · Sydney Cancer Centre at Concord Repatriation General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-02

Primary Completion

2025-02-07

Completion

2026-03-17

Countries

• United States
• Australia
• Canada
• France
• South Korea
• United Kingdom

Study Locations