Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
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Purpose
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.
| Condition |
|---|
|
Colorectal Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Health Behaviors Among Individuals Diagnosed With Colorectal Cancer |
- Self-efficacy for changing physical activity and dietary practices [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Outcome expectations with regard to physical activity and dietary practices [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Behavioral self-regulation of physical activity and dietary practices [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Perceived risk of CRC recurrence [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Receipt of healthcare provider recommendations to alter physical activity and diet [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
- Normative influences of family and friends [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 222 |
| Study Start Date: | November 2009 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
cancer survivor
cancer survivor
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
colorectal cancer
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
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | Elliot Coups, PhD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00966667 History of Changes |
| Other Study ID Numbers: | 130901, R21CA131611, P30CA072720, K07CA133100, CDR0000653167, 0220090178 |
| Study First Received: | August 26, 2009 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
cancer survivor stage I colon cancer stage II colon cancer stage III colon cancer |
stage I rectal cancer stage II rectal cancer stage III rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013