Colon Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

962

Study ID:

NCT00819208

Recruitment Status:

Recruiting

Sponsor:

Canadian Cancer Trials Group

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There are 46 Locations for this study

See Locations Near You

Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Steven Keteyian
Contact
313-916-9826
Dartmouth-Hitchcock
Lebanon New Hampshire, 03756, United States More Info
Mary Dickinson Chamberlin
Contact
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States More Info
Autumn McRee
Contact
919-966-3856
Armidale Hospital
Armidale New South Wales, 2350, Australia More Info
Nick Pavlakis
Contact
Bankstown-Lidcombe Hospital
Bankstown New South Wales, 2200, Australia More Info
Ray Asghari
Contact
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia More Info
Lisa Horvath
Contact
North Coast Cancer Institute Coffs Harbour
Coffs Harbour New South Wales, 2450, Australia More Info
Karen Briscoe
Contact
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia More Info
Philip Beale
Contact
2 9767-5112
Liverpool Hospital
Liverpool New South Wales, 2170, Australia More Info
Weng Ng
Contact
Newcastle Private Hospital
Newcastle New South Wales, 2305, Australia More Info
Antonino Bonaventura
Contact
North Coast Cancer Institute - Port Macquarie
Port Macquarie New South Wales, 2444, Australia More Info
Stephen Begbie
Contact
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia More Info
Stephen Clarke
Contact
2 9767-5112
Tamworth Hospital
Tamworth New South Wales, 2340, Australia More Info
Mathew George
Contact
2 6767-7789
Riverina Cancer Care Centre
Wagga Wagga New South Wales, 2650, Australia More Info
Renuka Chittajallu
Contact
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia More Info
Gavin Marx
Contact
Royal Brisbane and Women's Hospital
Herston Queensland, 4029, Australia More Info
Matthew E. Burge
Contact
07 3139-5863
Princess Alexandra
Woolloongabba Queensland, 4102, Australia More Info
Euan Walpole
Contact
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Nimit Singhal
Contact
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia More Info
Chris Karapetis
Contact
88 204-4830
The Queen Elizabeth Hospital
Woodville South Australia, 5011, Australia More Info
Tim Price
Contact
618 8222-8429
St Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia More Info
Melissa Moore
Contact
Royal Perth Hospital
Perth Western Australia, 6000, Australia More Info
Thomas Ferguson
Contact
Macarthur Cancer Therapy Centre - Campbelltown Hospital
Campbelltown , 2560, Australia More Info
Aflah Roohullah
Contact
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada More Info
Sasha Lupichuk
Contact
403 521-3688
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada More Info
Neil Sun Chua
Contact
780 432-8340
BCCA - Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada More Info
Howard Lim
Contact
604 877-6000
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada More Info
Ralph P.W. Wong
Contact
204 235-3044
Horizon Health Network
Fredericton New Brunswick, E3B 5, Canada More Info
M. Saleem Raza
Contact
506 447-4095
The Moncton Hospital
Moncton New Brunswick, E1C 6, Canada More Info
Mahmoud Abdelsalam
Contact
506 857-5104
Regional Health Authority B, Zone 2
Saint John New Brunswick, E2L 4, Canada More Info
Anthony J. Reiman
Contact
506 648-6884
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton Ontario, L8V 5, Canada More Info
John Goffin
Contact
905 387-9495
Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada More Info
Chris Booth
Contact
613 549-6666
Grand River Regional Cancer Centre
Kitchener Ontario, N2G 1, Canada More Info
Stacey Hubay
Contact
519 749-4370
London Regional Cancer Program
London Ontario, N6A 5, Canada More Info
Michael Sanatani
Contact
519 685-8640
Trillium Health Partners - Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada More Info
Saroosh Arif
Contact
416 521-4118
Stronach Regional Health Centre at Southlake
Newmarket Ontario, L3Y 2, Canada More Info
Shaqil Kassam
Contact
905 895-4521
Ottawa Hospital Research Institute
Ottawa Ontario, K1H 8, Canada More Info
Derek Jonker
Contact
613 737-7700
Niagara Health System
St. Catharines Ontario, L2S 0, Canada More Info
Radhika Yelamanchili
Contact
905 684-7271
Toronto Rehab
Toronto Ontario, M4G 1, Canada More Info
Monika K. Krzyzanowska
Contact
416 946-6542
Odette Cancer Centre
Toronto Ontario, M4N 3, Canada More Info
Kelvin K-W Chan
Contact
416 480-4928
Sinai Health System
Toronto Ontario, M5G 1, Canada More Info
Ronald L. Burkes
Contact
416 586-5117

Levis Quebec, G6V 3, Canada More Info
Vincent Barrette
Contact
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada More Info
Haji Ibrahim Chalchal
Contact
306 766-2691
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada More Info
Kamal Haider
Contact
306 655-2710

Montpellier 34298 , CEDEX, France More Info
Marc Ychou
Contact
46 761-3066
Exercise Medicine Center for Diabetes and Cancer
Seoul , , Korea, Republic of More Info
Justin Jeon
Contact
22 123-6197
Belfast City Hospital
Belfast Co. Antrim, BT9 7, United Kingdom More Info
Victoria Coyle
Contact
44028 95048492

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

962

Study ID:

NCT00819208

Recruitment Status:

Recruiting

Sponsor:


Canadian Cancer Trials Group

How clear is this clinincal trial information?

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