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 (Other)

Overall Status

Completed

CT.gov ID

NCT00966667

Collaborator

National Cancer Institute (NCI) (NIH), Rutgers Cancer Institute of New Jersey (Other)

222

Enrollment

Locations

117.2

Duration (Months)

15.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

222 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Health Behaviors Among Individuals Diagnosed With Colorectal Cancer

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 7, 2019

Actual Study Completion Date :

Aug 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
cancer survivor cancer survivor

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Cooper Hospital/University Medical Center	Camden	New Jersey	United States	08103
2	JFK Medical Center in Edison	Edison	New Jersey	United States	08818
3	Centrastate Healthcare System	Freehold	New Jersey	United States	07728
4	Robert Wood Johnson University Hospital at Hamilton	Hamilton	New Jersey	United States	08690
5	Mountainside Hospital	Montclair	New Jersey	United States	07042
6	Morristown Medical Center	Morristown	New Jersey	United States	07962
7	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754
8	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
9	Saint Peters University Hospital	New Brunswick	New Jersey	United States	08903
10	University Medical Center at Princeton	Princeton	New Jersey	United States	08540
11	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey	United States
12	Overlook Medical Center	Summit	New Jersey	United States	07901
13	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States
14	MD Anderson Cancer Center	Houston	Texas	United States	77030