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

Last updated: February 14, 2025
Sponsor: Canadian Cancer Trials Group
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Anxiety Disorders

Sleep Disorders

Depression

Treatment

counseling intervention

laboratory biomarker analysis

quality-of-life assessment

Clinical Study ID

NCT00819208
CO21
CDR0000629834
CAN-NCIC-CO21
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Completely resected histologically confirmed adenocarcinoma of the colon

  • High-risk stage II disease, including one of the following:

  • T4 lesions

  • Less than 12 sampled lymph nodes

  • Poorly differentiated histology

  • Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit.

  • Synchronous primary colon cancer allowed

  • Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle.

  • Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration.

  • Carcinoembryonic antigen (CEA) ≤ 5 μg/L

  • Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ)

  • Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer.

  • Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response

  • No rectal cancer

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1

  • Absolute granulocyte count ≥ 1,000/mm³

  • Platelet count ≥ 100,000/mm³

  • Hemoglobin ≥ 100 g/L

  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

  • Alkaline phosphatase < 2.5 times ULN

  • ALT < 2 times ULN

  • Not pregnant or planning to become pregnant within the next 3 years

  • Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center

  • Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs

  • Able to complete the baseline exercise test

  • No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator

  • Likely to participate in a physical activity program, as assessed by the investigator

  • No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for > 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior radiotherapy as a component of treatment for primary tumor

  • No concurrent treatment with additional chemotherapy or radiation

  • No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program

  • No concurrent anticancer treatment including chemotherapy, biological, or targeted agents

Study Design

Total Participants: 889
Treatment Group(s): 10
Primary Treatment: counseling intervention
Phase:
Study Start date:
June 02, 2009
Estimated Completion Date:
December 15, 2030

Study Description

OBJECTIVES:

Primary

  • To compare the disease-free survival (DFS) of medically fit patients who have completed surgical resection and adjuvant chemotherapy for high-risk stage II or stage III colon cancer when administered a physical activity program with general health education materials vs general health education materials alone.

Secondary

  • To compare the two intervention arms with respect to overall survival (OS); patient-reported outcomes using the SF-36, FACIT-F, PSQI, and HADS questionnaires; objective markers of physical fitness using body mass index, hip and waist circumference, submaximal exercise testing, and the Seniors' Fitness Test; physical activity behavior using the Total Physical Activity Questionnaire (TPAQ); safety profile as assessed by NCI CTCAE version 3.0; serum levels of insulin (i.e., IGF-1, IGF-2, and IGFBP3); cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF) and C-reactive protein levels; economic evaluations including cost-effective and cost-utility analyses; and predictors of physical activity adherence using the Social-Cognitive Determinants of Exercise Measure questionnaire.

  • To evaluate the potential prognostic associations of the serum levels of insulin, IGF-1, IGF-2, IGFBP3, blood glucose, cytokines (i.e., IL- 1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein with DFS, OS, level of physical activity, and level of fatigue in these patients.

  • To evaluate the potential prognostic associations of age, gender, country, incremental increase in physical activity, and change in cardiovascular fitness with DFS, OS, level of fatigue, and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III), participating center, body mass index (≤ 27.5 vs > 27.5), and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment interventions.

  • Arm I: Patients receive general health education materials regarding nutrition and physical activity and undergo the Colon Health And Life Long Exercise Change (CHALLENGE) physical activity program consisting of behavior-support sessions and supervised physical activity sessions with a physical activity consultant.

    • Part I (intensive intervention for 6 months): Patients undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 metabolic equivalent task (MET) hours/week. Twelve supervised physical activity sessions are also recommended on alternate weeks.

    • Part II (reduced intervention for months 6-12): Patients undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.

    • Part III (minimal intervention for months 12-36): Patients undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.

  • Arm II: Patients receive general health education materials regarding nutrition and physical activity.

Patients complete the Total Physical Activity Questionnaire (TPAQ) to assess exercise participation and undergo fitness testing periodically by the submaximal exercise test and Seniors' Fitness Test (SFT).

Patients complete the SF-36, FACT-F, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Social Cognitive Determinants of Exercise Measure questionnaires periodically. Patients also complete a 30-day resource use diary and undergo a health economics analysis by the Work Productivity and Activity Impairment (WPAI) questionnaire.

Blood samples are collected periodically for correlative studies and fasting glucose. Samples are analyzed for markers of insulin level, IGF-1, IGF-2, and IGFBP3, cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein levels.

During the 3 year intervention period, patients are followed every 6 months for 3 years and then annually for 4-10 years.

Connect with a study center

  • Armidale Hospital

    Armidale, New South Wales 2350
    Australia

    Site Not Available

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Southern Highlands Cancer Centre

    Bowral, New South Wales 2576
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • North Coast Cancer Institute Coffs Harbour

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Newcastle Private Hospital

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • North Coast Cancer Institute - Port Macquarie

    Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Tamworth Hospital

    Tamworth, New South Wales 2340
    Australia

    Site Not Available

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales 2650
    Australia

    Site Not Available

  • Sydney Adventist Hospital

    Wahroonga, New South Wales 2076
    Australia

    Site Not Available

  • Border Medical Oncology

    Wodonga, New South Wales 3690
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Princess Alexandra

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • The Queen Elizabeth Hospital

    Woodville, South Australia 5011
    Australia

    Site Not Available

  • Ballarat Health Services

    Ballarat, Victoria 3353
    Australia

    Site Not Available

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Macarthur Cancer Therapy Centre - Campbelltown Hospital

    Campbelltown, 2560
    Australia

    Site Not Available

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • CancerCare Manitoba

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Horizon Health Network

    Fredericton, New Brunswick E3B 5N5
    Canada

    Site Not Available

  • The Moncton Hospital

    Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick E2L 4L2
    Canada

    Site Not Available

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • Kingston Health Sciences Centre

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Grand River Regional Cancer Centre

    Kitchener, Ontario N2G 1G3
    Canada

    Site Not Available

  • London Regional Cancer Program

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Niagara Health System

    St. Catharines, Ontario L2S 0A9
    Canada

    Site Not Available

  • Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Sinai Health System

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Toronto Rehab

    Toronto, Ontario M4G 1R7
    Canada

    Site Not Available

  • Levis, Quebec G6V 3Z1
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan S7N 4H4
    Canada

    Site Not Available

  • Montpellier 34298, CEDEX 5
    France

    Site Not Available

  • Exercise Medicine Center for Diabetes and Cancer

    Seoul,
    Korea, Republic of

    Site Not Available

  • Belfast City Hospital

    Belfast, Co. Antrim BT9 7AB
    United Kingdom

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-1651
    United States

    Site Not Available

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