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 (CHALLENGE)
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 and 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Disease-free survival
10 years
No
Kerry Courneya, PhD
Study Chair
University of Alberta
Canada: Health Canada
CO21
NCT00819208
December 2008
December 2030
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