Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00966667
Status:
COMPLETED
Last Update Posted:
2019-09-10
First Post:
2009-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
Health Behaviors Among Individuals Diagnosed With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21CA131611 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA072720 | NIH | None | https://reporter.nih.gov/quic… | View |
| K07CA133100 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000653167 | OTHER | NIH | View | |
| 0220090178 | OTHER | IRB | View |