CHALLENGE: 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

Sponsor

Canadian Cancer Trials Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT00819208

Collaborator

Survivorship Research Group (Other), Queen's University, Belfast (Other)

962

Enrollment

Locations

Arms

264.4

Anticipated Duration (Months)

19.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Cognitive/Functional Effects Colorectal Cancer Depression Fatigue Psychosocial Effects of Cancer and Its Treatment Sleep Disorders Excercise	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: Educational Intervention Other: Fitness testing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

962 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Dec 3, 2008

Anticipated Primary Completion Date :

Dec 15, 2029

Anticipated Study Completion Date :

Dec 15, 2030

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physical Activity Program + General Health Education Materials Intervention Arm	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: Fitness testing Objective fitness testing for both arms
Active Comparator: General Health Education Materials Control Arm	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

Arm

Intervention/Treatment

Active Comparator: Physical Activity Program + General Health Education Materials

Intervention Arm

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: Fitness testing

Objective fitness testing for both arms

Active Comparator: General Health Education Materials

Control Arm

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

Outcome Measures

Primary Outcome Measures

Disease-free survival [10 years]

Secondary Outcome Measures

Overall survival [10 years]
Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires [5 years]
Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function) [3 years]
Physical activity behavior as assessed by TPAQ [5 years]
Safety profile according to NCI CTCAE version 3.0 [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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202
2	Dartmouth-Hitchcock	Lebanon	New Hampshire	United States	03756
3	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-1651
4	Armidale Hospital	Armidale	New South Wales	Australia	2350
5	Bankstown-Lidcombe Hospital	Bankstown	New South Wales	Australia	2200
6	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
7	North Coast Cancer Institute Coffs Harbour	Coffs Harbour	New South Wales	Australia	2450
8	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
9	Liverpool Hospital	Liverpool	New South Wales	Australia	2170
10	Newcastle Private Hospital	Newcastle	New South Wales	Australia	2305
11	North Coast Cancer Institute - Port Macquarie	Port Macquarie	New South Wales	Australia	2444
12	Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
13	Royal North Shore Hospital	St Leonards	New South Wales	Australia	2065
14	Tamworth Hospital	Tamworth	New South Wales	Australia	2340
15	Riverina Cancer Care Centre	Wagga Wagga	New South Wales	Australia	2650
16	Sydney Adventist Hospital	Wahroonga	New South Wales	Australia	2076
17	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	4029
18	Princess Alexandra	Woolloongabba	Queensland	Australia	4102
19	Royal Adelaide Hospital	Adelaide	South Australia	Australia	5000
20	Flinders Medical Centre	Bedford Park	South Australia	Australia	5042
21	The Queen Elizabeth Hospital	Woodville	South Australia	Australia	5011
22	Ballarat Health Services	Ballarat	Victoria	Australia	3353
23	St Vincent's Hospital Melbourne	Fitzroy	Victoria	Australia	3065
24	Royal Perth Hospital	Perth	Western Australia	Australia	6000
25	Macarthur Cancer Therapy Centre - Campbelltown Hospital	Campbelltown		Australia	2560
26	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
27	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
28	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
29	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
30	Horizon Health Network	Fredericton	New Brunswick	Canada	E3B 5N5
31	The Moncton Hospital	Moncton	New Brunswick	Canada	E1C 6Z8
32	Regional Health Authority B, Zone 2	Saint John	New Brunswick	Canada	E2L 4L2
33	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8V 5C2
34	Kingston Health Sciences Centre	Kingston	Ontario	Canada	K7L 2V7
35	Grand River Regional Cancer Centre	Kitchener	Ontario	Canada	N2G 1G3
36	London Regional Cancer Program	London	Ontario	Canada	N6A 5W9
37	Trillium Health Partners - Credit Valley Hospital	Mississauga	Ontario	Canada	L5M 2N1
38	Stronach Regional Health Centre at Southlake	Newmarket	Ontario	Canada	L3Y 2P9
39	Ottawa Hospital Research Institute	Ottawa	Ontario	Canada	K1H 8L6
40	Niagara Health System	St. Catharines	Ontario	Canada	L2S 0A9
41	Toronto Rehab	Toronto	Ontario	Canada	M4G 1R7
42	Odette Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
43	Sinai Health System	Toronto	Ontario	Canada	M5G 1X5
44	University Health Network	Toronto	Ontario	Canada	M5G 2M9
45		Levis	Quebec	Canada	G6V 3Z1
46	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1
47	Saskatoon Cancer Centre	Saskatoon	Saskatchewan	Canada	S7N 4H4
48		Montpellier 34298		France	CEDEX 5
49	Exercise Medicine Center for Diabetes and Cancer	Seoul		Korea, Republic of
50	Belfast City Hospital	Belfast	Co. Antrim	United Kingdom	BT9 7AB

Sponsors and Collaborators

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

Investigators

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