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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00819208




Registration number
NCT00819208
Ethics application status
Date submitted
7/01/2009
Date registered
8/01/2009

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
CAN-NCIC-CO21
Secondary ID [2] 0 0
CO21
Universal Trial Number (UTN)
Trial acronym
CHALLENGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorder 0 0
Cognitive/Functional Effects 0 0
Colorectal Cancer 0 0
Depression 0 0
Fatigue 0 0
Psychosocial Effects of Cancer and Its Treatment 0 0
Sleep Disorders 0 0
Excercise 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - exercise intervention
Other interventions - counseling intervention
Other interventions - educational intervention
Other interventions - laboratory biomarker analysis
Other interventions - questionnaire administration
Other interventions - study of socioeconomic and demographic variables
Treatment: Surgery - fatigue assessment and management
Treatment: Surgery - quality-of-life assessment
Other interventions - Educational Intervention
Other interventions - Fitness testing

Active comparator: Physical Activity Program + General Health Education Materials - Intervention Arm

Active comparator: General Health Education Materials - Control 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 interventions: 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 interventions: educational intervention
Once at the beginning of the program

Other interventions: laboratory biomarker analysis
Every 12 months

Other interventions: questionnaire administration
Every 6 months

Other interventions: study of socioeconomic and demographic variables
Every 6 months

Treatment: Surgery: fatigue assessment and management
Every 6 months

Treatment: Surgery: quality-of-life assessment
Every 6 months

Other interventions: Educational Intervention
For Arm 2 just once at beginning of program.

Other interventions: Fitness testing
Objective fitness testing for both arms
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free survival
Timepoint [1] 0 0
10 years
Secondary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Patient-reported outcomes, including quality of life, using SF-36, FACIT-F, PSQI, and HADS questionnaires
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Physical activity behavior as assessed by TPAQ
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Safety profile according to NCI CTCAE version 3.0
Timepoint [5] 0 0
10 years
Secondary outcome [6] 0 0
Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Economic evaluations including cost-effective analysis and cost utility analysis
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Predictors of physical activity adherence as assessed by Social Cognitive Determinants of Exercise questionnaire
Timepoint [8] 0 0
3 years

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2030
Actual
Sample size
Target
Accrual to date
Final
889
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Armidale Hospital - Armidale
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 0 0
North Coast Cancer Institute Coffs Harbour - Coffs Harbour
Recruitment hospital [5] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [6] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [7] 0 0
Newcastle Private Hospital - Newcastle
Recruitment hospital [8] 0 0
North Coast Cancer Institute - Port Macquarie - Port Macquarie
Recruitment hospital [9] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 0 0
Tamworth Hospital - Tamworth
Recruitment hospital [11] 0 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [12] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [13] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [14] 0 0
Princess Alexandra - Woolloongabba
Recruitment hospital [15] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [17] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [18] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [19] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [20] 0 0
Macarthur Cancer Therapy Centre - Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 0 0
2350 - Armidale
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2305 - Newcastle
Recruitment postcode(s) [8] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [9] 0 0
2065 - St Leonards
Recruitment postcode(s) [10] 0 0
2340 - Tamworth
Recruitment postcode(s) [11] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [12] 0 0
2076 - Wahroonga
Recruitment postcode(s) [13] 0 0
4029 - Herston
Recruitment postcode(s) [14] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
5042 - Bedford Park
Recruitment postcode(s) [17] 0 0
5011 - Woodville
Recruitment postcode(s) [18] 0 0
3065 - Fitzroy
Recruitment postcode(s) [19] 0 0
6000 - Perth
Recruitment postcode(s) [20] 0 0
2560 - Campbelltown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
New Hampshire
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
New Brunswick
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Saskatchewan
Country [11] 0 0
France
State/province [11] 0 0
Montpellier 34298
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Co. Antrim

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Survivorship Research Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Queen's University, Belfast
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kerry Courneya, PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreic... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT00819208