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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Canadian Cancer Trials Group
Study ID
NCT00819208
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • exercise intervention — BEHAVIORAL
    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
  • counseling intervention — OTHER
    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.
  • educational intervention — OTHER
    Once at the beginning of the program
  • laboratory biomarker analysis — OTHER
    Every 12 months
  • questionnaire administration — OTHER
    Every 6 months
  • study of socioeconomic and demographic variables — OTHER
    Every 6 months
  • fatigue assessment and management — PROCEDURE
    Every 6 months
  • quality-of-life assessment — PROCEDURE
    Every 6 months
  • Educational Intervention — OTHER
    For Arm 2 just once at beginning of program.
  • Fitness testing — OTHER
    Objective fitness testing for both arms

Study Details

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.

Key Dates

Start date
Jun 2, 2009
Status verified
Apr 2026
Primary completion
Feb 7, 2025
Completion
Mar 17, 2026

Study Design

Enrollment
889 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Physical Activity Program + General Health Education Materials
    Intervention Arm
  • Active Comparator: General Health Education Materials
    Control Arm

Primary Outcome Measure

Disease-free Survival [ Time Frame: 5 Years after randomization ]

Locations (3)

FacilityCityStateZIPSite coordinators
Henry Ford HospitalDetroitMichigan48202-
Dartmouth-HitchcockLebanonNew Hampshire03756-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-1651-

Find similar trials in Detroit, MI

By condition
Colorectal cancerDepression
By specialty
OncologyGI oncologyPsychiatryMental healthBehavioral health
By research site
Henry Ford Hospital· Detroit, MIDartmouth-Hitchcock· Lebanon, NHUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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