Overview

This trial is active, not recruiting.

Condition colorectal cancer
Sponsor Rutgers, The State University of New Jersey
Collaborator National Cancer Institute (NCI)
Start date November 2009
End date August 2017
Trial size 222 participants
Trial identifier NCT00966667, 0220090178, 130901, CDR0000653167, K07CA133100, P30CA072720, R21CA131611

Summary

RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.

PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective
Arm
cancer survivor

Primary Outcomes

Measure
Self-efficacy for changing physical activity and dietary practices
time frame: 3 yrs
Outcome expectations with regard to physical activity and dietary practices
time frame: 3 yrs
Behavioral self-regulation of physical activity and dietary practices
time frame: 3 yrs
Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations)
time frame: 3 yrs
Perceived risk of CRC recurrence
time frame: 3 yrs
Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC)
time frame: 3 yrs
Receipt of healthcare provider recommendations to alter physical activity and diet
time frame: 3 yrs
Normative influences of family and friends
time frame: 3 yrs

Eligibility Criteria

Male or female participants at least 21 years old.

DISEASE CHARACTERISTICS: - Diagnosis of localized or regional colorectal cancer - Stage I, II, or III disease - Completed treatment within the past 6 weeks - No previous diagnosis of colorectal cancer PATIENT CHARACTERISTICS: - English speaking - No current evidence of neoplastic disease except for nonmelanoma skin cancer - No evidence of severe cognitive impairment PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Health Behaviors Among Individuals Diagnosed With Colorectal Cancer
Principal investigator Elliot Coups, PhD
Description OBJECTIVES: Primary - To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors. Secondary - To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients. - To identify these patients' preferences regarding diet and physical activity health promotion programs. OUTLINE: This is a multicenter study. Patients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined. During each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them. Measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey.