Last updated on April 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Sleep Disorders | ANXIETY NEUROSIS | Colorectal Cancer | Excercise | Psychosocial Effects of Cancer and Its Treatment | Fatigue | Cognitive/Functional Effects | Endogenous depression | Depression
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 g/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/mm
  • Platelet count 100,000/mm
  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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