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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by NCIC Clinical Trials Group
Sponsor:
Collaborator:
Survivorship Research Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00819208
First received: January 7, 2009
Last updated: September 16, 2014
Last verified: March 2014
  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)

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 at all sessions form Arm 1. For Arm 2 just once at beginning of 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
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
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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819208

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

  Show 46 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Survivorship Research Group
Investigators
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: September 16, 2014
Health Authority: Canada: NCIC Clinical Trials Group

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:
Depression
Depressive Disorder
Colorectal Neoplasms
Fatigue
Anxiety Disorders
Sleep Disorders
Parasomnias
Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014