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
- Conditions
- Anxiety DisorderCognitive/Functional EffectsColorectal CancerPsychosocial Effects of Cancer and Its TreatmentSleep DisordersExcerciseDepressionFatigue
- Interventions
- Behavioral: exercise interventionOther: counseling interventionOther: study of socioeconomic and demographic variablesOther: laboratory biomarker analysisOther: questionnaire administrationOther: Educational InterventionProcedure: fatigue assessment and managementProcedure: quality-of-life assessmentOther: Fitness testing
- Registration Number
- NCT00819208
- Lead Sponsor
- Canadian Cancer Trials Group
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 889
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Activity Program + General Health Education Materials questionnaire administration Intervention Arm Physical Activity Program + General Health Education Materials quality-of-life assessment Intervention Arm Physical Activity Program + General Health Education Materials Fitness testing Intervention Arm Physical Activity Program + General Health Education Materials exercise intervention Intervention Arm General Health Education Materials study of socioeconomic and demographic variables Control Arm Physical Activity Program + General Health Education Materials laboratory biomarker analysis Intervention Arm Physical Activity Program + General Health Education Materials study of socioeconomic and demographic variables Intervention Arm Physical Activity Program + General Health Education Materials fatigue assessment and management Intervention Arm General Health Education Materials laboratory biomarker analysis Control Arm General Health Education Materials questionnaire administration Control Arm General Health Education Materials Educational Intervention Control Arm Physical Activity Program + General Health Education Materials counseling intervention Intervention Arm Physical Activity Program + General Health Education Materials Educational Intervention Intervention Arm General Health Education Materials quality-of-life assessment Control Arm General Health Education Materials Fitness testing Control Arm General Health Education Materials fatigue assessment and management Control Arm
- Primary Outcome Measures
Name Time Method Disease-free survival 10 years
- Secondary Outcome Measures
Name Time Method Overall survival 10 years Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue 3 years Physical activity behavior as assessed by TPAQ 5 years Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) 3 years Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires 5 years Safety profile according to NCI CTCAE version 3.0 10 years Economic evaluations including cost-effective analysis and cost utility analysis 5 years Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire 3 years
Trial Locations
- Locations (45)
Newcastle Private Hospital
🇦🇺Newcastle, New South Wales, Australia
Princess Alexandra
🇦🇺Woolloongabba, Queensland, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
North Coast Cancer Institute - Port Macquarie
🇦🇺Port Macquarie, New South Wales, Australia
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Belfast City Hospital
🇬🇧Belfast, Co. Antrim, United Kingdom
Tamworth Hospital
🇦🇺Tamworth, New South Wales, Australia
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Bankstown-Lidcombe Hospital
🇦🇺Bankstown, New South Wales, Australia
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Armidale Hospital
🇦🇺Armidale, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Macarthur Cancer Therapy Centre - Campbelltown Hospital
🇦🇺Campbelltown, Australia
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Exercise Medicine Center for Diabetes and Cancer
🇰🇷Seoul, Korea, Republic of
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Stronach Regional Health Centre at Southlake
🇨🇦Newmarket, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Sinai Health System
🇨🇦Toronto, Ontario, Canada
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
North Coast Cancer Institute Coffs Harbour
🇦🇺Coffs Harbour, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Trillium Health Partners - Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Dartmouth-Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Horizon Health Network
🇨🇦Fredericton, New Brunswick, Canada
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Regional Health Authority B, Zone 2
🇨🇦Saint John, New Brunswick, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Toronto Rehab
🇨🇦Toronto, Ontario, Canada
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Riverina Cancer Care Centre
🇦🇺Wagga Wagga, New South Wales, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
Grand River Regional Cancer Centre
🇨🇦Kitchener, Ontario, Canada