Health Education Materials With or Without a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder Cognitive/Functional Effects Colorectal Cancer Depression Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders |
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 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 (CHALLENGE) |
- Disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Physical activity behavior as assessed by TPAQ [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Safety profile according to NCI CTCAE version 3.0 [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Economic evaluations including cost-effective analysis and cost utility analysis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 962 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2030 |
| Estimated Primary Completion Date: | December 2029 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Every 6 months
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
|
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
- No metastatic or locally recurrent disease as assessed by chest x-ray or CT scan and CT, MRI or Ultrasound of the abdomen/pelvis.
- 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
- AST or 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| Contact: Ralph Meyer, M.D | 613-533-6430 | rmeyer@ctg.queensu.ca |
Show 43 Study Locations| 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
Additional Information:
Publications:
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00819208 History of Changes |
| Other Study ID Numbers: | CO21, CAN-NCIC-CO21, CDR0000629834 |
| Study First Received: | January 7, 2009 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by NCIC Clinical 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:
|
Anxiety Disorders Colonic Neoplasms Colorectal Neoplasms Depression Depressive Disorder Fatigue Sleep Disorders Parasomnias Mental Disorders Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Behavioral Symptoms Mood Disorders Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 16, 2013