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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)

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ClinicalTrials.gov Identifier: NCT00819208
Recruitment Status : Recruiting
First Posted : January 8, 2009
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Survivorship Research Group
Queen's University, Belfast
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE January 7, 2009
First Posted Date  ICMJE January 8, 2009
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE December 3, 2008
Estimated Primary Completion Date December 15, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2011)
Disease-free survival [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
Disease-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Overall survival [ Time Frame: 10 years ]
  • Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires [ Time Frame: 5 years ]
  • Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) [ Time Frame: 3 years ]
  • Physical activity behavior as assessed by TPAQ [ Time Frame: 5 years ]
  • Safety profile according to NCI CTCAE version 3.0 [ Time Frame: 10 years ]
  • 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 ]
  • Economic evaluations including cost-effective analysis and cost utility analysis [ Time Frame: 5 years ]
  • Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2009)
  • Overall survival
  • Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires
  • Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
  • Physical activity behavior as assessed by TPAQ
  • Safety profile according to NCI CTCAE version 3.0
  • Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue
  • Economic evaluations including cost-effective analysis and cost utility analysis
  • Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description

OBJECTIVES:

Primary

  • To compare the disease-free survival (DFS) of medically fit patients who have completed surgical resection and adjuvant chemotherapy for high-risk stage II or stage III colon cancer when administered a physical activity program with general health education materials vs general health education materials alone.

Secondary

  • To compare the two intervention arms with respect to overall survival (OS); patient-reported outcomes using the SF-36, FACIT-F, PSQI, and HADS questionnaires; objective markers of physical fitness using body mass index, hip and waist circumference, submaximal exercise testing, and the Seniors' Fitness Test; physical activity behavior using the Total Physical Activity Questionnaire (TPAQ); safety profile as assessed by NCI CTCAE version 3.0; serum levels of insulin (i.e., IGF-1, IGF-2, and IGFBP3); cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF) and C-reactive protein levels; economic evaluations including cost-effective and cost-utility analyses; and predictors of physical activity adherence using the Social-Cognitive Determinants of Exercise Measure questionnaire.
  • To evaluate the potential prognostic associations of the serum levels of insulin, IGF-1, IGF-2, IGFBP3, blood glucose, cytokines (i.e., IL- 1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein with DFS, OS, level of physical activity, and level of fatigue in these patients.
  • To evaluate the potential prognostic associations of age, gender, country, incremental increase in physical activity, and change in cardiovascular fitness with DFS, OS, level of fatigue, and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III), participating center, body mass index (≤ 27.5 vs > 27.5), and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment interventions.

  • Arm I: Patients receive general health education materials regarding nutrition and physical activity and undergo the Colon Health And Life Long Exercise Change (CHALLENGE) physical activity program consisting of behavior-support sessions and supervised physical activity sessions with a physical activity consultant.

    • Part I (intensive intervention for 6 months): Patients undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 metabolic equivalent task (MET) hours/week. Twelve supervised physical activity sessions are also recommended on alternate weeks.
    • Part II (reduced intervention for months 6-12): Patients undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.
    • Part III (minimal intervention for months 12-36): Patients undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.
  • Arm II: Patients receive general health education materials regarding nutrition and physical activity.

Patients complete the Total Physical Activity Questionnaire (TPAQ) to assess exercise participation and undergo fitness testing periodically by the submaximal exercise test and Seniors' Fitness Test (SFT).

Patients complete the SF-36, FACT-F, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Social Cognitive Determinants of Exercise Measure questionnaires periodically. Patients also complete a 30-day resource use diary and undergo a health economics analysis by the Work Productivity and Activity Impairment (WPAI) questionnaire.

Blood samples are collected periodically for correlative studies and fasting glucose. Samples are analyzed for markers of insulin level, IGF-1, IGF-2, and IGFBP3, cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein levels.

During the 3 year intervention period, patients are followed every 6 months for 3 years and then annually for 4-10 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Anxiety Disorder
  • Cognitive/Functional Effects
  • Colorectal Cancer
  • Depression
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • Excercise
Intervention  ICMJE
  • 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: Educational Intervention
    For Arm 2 just once at beginning of program.
  • Other: Fitness testing
    Objective fitness testing for both arms
Study Arms  ICMJE
  • Active Comparator: Physical Activity Program + General Health Education Materials
    Intervention Arm
    Interventions:
    • 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: Fitness testing
  • Active Comparator: General Health Education Materials
    Control Arm
    Interventions:
    • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2009)
962
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2030
Estimated Primary Completion Date December 15, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chris O'Callaghan 613-533-6430 cocallaghan@ctg.queensu.ca
Listed Location Countries  ICMJE Australia,   Canada,   France,   Korea, Republic of,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00819208
Other Study ID Numbers  ICMJE CO21
CAN-NCIC-CO21 ( Registry Identifier: NCI US - Physician Data Query )
CDR0000629834 ( Other Identifier: PDQ )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE
  • Survivorship Research Group
  • Queen's University, Belfast
Investigators  ICMJE
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
PRS Account Canadian Cancer Trials Group
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP