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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 (CHALLENGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00819208
Recruitment Status : Recruiting
First Posted : January 8, 2009
Last Update Posted : March 15, 2023
Sponsor:
Collaborators:
Survivorship Research Group
Queen's University, Belfast
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Anxiety Disorder Cognitive/Functional Effects Colorectal Cancer Depression Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders Excercise Behavioral: exercise intervention Other: counseling intervention Other: educational intervention Other: laboratory biomarker analysis Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: fatigue assessment and management Procedure: quality-of-life assessment Other: Educational Intervention Other: Fitness testing Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 962 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial
Actual Study Start Date : December 3, 2008
Estimated Primary Completion Date : December 15, 2029
Estimated Study Completion Date : December 15, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Physical Activity Program + General Health Education Materials
Intervention Arm
 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: Fitness testing
Objective fitness testing for both arms
Active Comparator: General Health Education Materials
Control Arm
 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


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 10 years ]
  2. Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires [ Time Frame: 5 years ]
  3. Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) [ Time Frame: 3 years ]
  4. Physical activity behavior as assessed by TPAQ [ Time Frame: 5 years ]
  5. Safety profile according to NCI CTCAE version 3.0 [ Time Frame: 10 years ]
  6. Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue [ Time Frame: 3 years ]
  7. Economic evaluations including cost-effective analysis and cost utility analysis [ Time Frame: 5 years ]
  8. Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00819208


Contacts
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Contact: Chris O'Callaghan 613-533-6430 cocallaghan@ctg.queensu.ca

Locations
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Sponsors and Collaborators
Canadian Cancer Trials Group
Survivorship Research Group
Queen's University, Belfast
Investigators
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Study Chair: Kerry Courneya, PhD University of Alberta
Study Chair: Christopher Booth, MD Cancer Centre of Southeastern Ontario at Kingston General Hospital
Study Chair: Janette Vardy, PhD, FRACP Sydney Cancer Centre at Concord Repatriation General Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT00819208    
Other Study ID Numbers: CO21
CAN-NCIC-CO21 ( Registry Identifier: NCI US - Physician Data Query )
CDR0000629834 ( Other Identifier: PDQ )
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group:
fatigue
sleep disorders
depression
anxiety disorder
psychosocial effects of cancer and its treatment
 cognitive/functional effects
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colonic Neoplasms
Sleep Wake Disorders
Parasomnias
Disease
Fatigue
Depression
Anxiety Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Colorectal Neoplasms
 Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Nervous System Diseases
Neurologic Manifestations