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

Depression Clinical Trial

— CHALLENGE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00819208
• Other study ID #: CO21
• Secondary ID: CAN-NCIC-CO21CDR
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2009
• Est. completion date: December 15, 2030

Study information

• Verified date: January 2024
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 889
• Est. completion date: December 15, 2030
• Est. primary completion date: December 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Cognitive/Functional Effects
• Colonic Neoplasms
• Colorectal Cancer
• Depression
• Excercise
• Fatigue
• Parasomnias
• Psychosocial Effects of Cancer and Its Treatment
• Sleep Disorders
• Sleep Wake Disorders

Intervention

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.
• educational intervention
Once at the beginning of the program
• laboratory biomarker analysis
Every 12 months
• questionnaire administration
Every 6 months
• study of socioeconomic and demographic variables
Every 6 months

Procedure:
• fatigue assessment and management
Every 6 months
• quality-of-life assessment
Every 6 months

Other:
• Educational Intervention
For Arm 2 just once at beginning of program.
• Fitness testing
Objective fitness testing for both arms

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Armidale Hospital	Armidale	New South Wales
Australia	Bankstown-Lidcombe Hospital	Bankstown	New South Wales
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Macarthur Cancer Therapy Centre - Campbelltown Hospital	Campbelltown
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	North Coast Cancer Institute Coffs Harbour	Coffs Harbour	New South Wales
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Newcastle Private Hospital	Newcastle	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	North Coast Cancer Institute - Port Macquarie	Port Macquarie	New South Wales
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Tamworth Hospital	Tamworth	New South Wales
Australia	Riverina Cancer Care Centre	Wagga Wagga	New South Wales
Australia	Sydney Adventist Hospital	Wahroonga	New South Wales
Australia	The Queen Elizabeth Hospital	Woodville	South Australia
Australia	Princess Alexandra	Woolloongabba	Queensland
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Horizon Health Network	Fredericton	New Brunswick
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	Grand River Regional Cancer Centre	Kitchener	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	Trillium Health Partners - Credit Valley Hospital	Mississauga	Ontario
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	Stronach Regional Health Centre at Southlake	Newmarket	Ontario
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Regional Health Authority B, Zone 2	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Niagara Health System	St. Catharines	Ontario
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	Sinai Health System	Toronto	Ontario
Canada	Toronto Rehab	Toronto	Ontario
Canada	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Korea, Republic of	Exercise Medicine Center for Diabetes and Cancer	Seoul
United Kingdom	Belfast City Hospital	Belfast	Co. Antrim
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Henry Ford Hospital	Detroit	Michigan
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	Queen's University, Belfast, Survivorship Research Group

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Korea, Republic of,  United Kingdom, 

References & Publications (3)

Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85. doi: 10.3747/co.v15i6.378. — View Citation

Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of — View Citation

Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801. doi: 10.1123/jpah.7.6.794. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		10 years
Secondary	Overall survival		10 years
Secondary	Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires		5 years
Secondary	Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)		3 years
Secondary	Physical activity behavior as assessed by TPAQ		5 years
Secondary	Safety profile according to NCI CTCAE version 3.0		10 years
Secondary	Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue		3 years
Secondary	Economic evaluations including cost-effective analysis and cost utility analysis		5 years
Secondary	Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire		3 years