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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 not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), January 2009
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00819208
  Purpose

RATIONALE: Participating in a physical activity program and receiving written health education materials may improve 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
Cancer-Related Problem/Condition
Colorectal Cancer
Fatigue
Procedure: counseling
Procedure: educational intervention
Procedure: exercise intervention
Procedure: fatigue assessment and management
Procedure: laboratory biomarker analysis
Procedure: quality-of-life assessment
Procedure: questionnaire administration
Procedure: study of socioeconomic and demographic variables
Phase III

MedlinePlus related topics: Anxiety Cancer Colorectal Cancer Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control
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)

Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires [ Designated as safety issue: No ]
  • Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) [ Designated as safety issue: No ]
  • Physical activity behavior as assessed by TPAQ [ Designated as safety issue: No ]
  • Safety profile according to NCI CTCAE version 3.0 [ 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 [ Designated as safety issue: No ]
  • Economic evaluations including cost-effective analysis and cost utility analysis [ Designated as safety issue: No ]
  • Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire [ Designated as safety issue: No ]

Estimated Enrollment: 962
Study Start Date: December 2008
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
    • Synchronous primary colon cancer allowed
  • Must have undergone complete surgical resection AND completed ≥ 1 course of adjuvant chemotherapy with a 5-fluoroucacil-based regimen within the past 60-180 days
  • 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

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,000/mm³ OR 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 normal
  • Alkaline phosphatase < 2.5 times ULN
  • AST or ALT < 1.5 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819208

Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Kerry Courneya, PhD University of Alberta Hospital
Investigator: Sharlene Gill, MD British Columbia Cancer Agency
Investigator: Janette Vardy, PhD, FRACP Sydney Cancer Centre at Concord Repatriation General Hospital
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: CDR0000629834, CAN-NCIC-CO21
Study First Received: January 7, 2009
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00819208  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
fatigue
sleep disorders
depression
anxiety disorder
psychosocial effects/treatment
cognitive/functional effects
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

Study placed in the following topic categories:
Fatigue
Depression
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Sleep Disorders
Intestinal Diseases
Depressive Disorder
Rectal Diseases
Intestinal Neoplasms
Signs and Symptoms
Digestive System Diseases
Anxiety Disorders
Gastrointestinal Neoplasms
Adenocarcinoma
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009