Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Health Behaviors Among Individuals Diagnosed With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966667
• Other study ID #: 130901
• Secondary ID: R21CA131611P30CA
• Status: Completed
• Start date: November 2009
• Est. completion date: August 7, 2019

Study information

• Verified date: September 2019
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	JFK Medical Center in Edison	Edison	New Jersey
United States	Centrastate Healthcare System	Freehold	New Jersey
United States	Robert Wood Johnson University Hospital at Hamilton	Hamilton	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mountainside Hospital	Montclair	New Jersey
United States	Morristown Medical Center	Morristown	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Saint Peters University Hospital	New Brunswick	New Jersey
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University Medical Center at Princeton	Princeton	New Jersey
United States	Robert Wood Johnson University Hospital Somerset	Somerville	New Jersey
United States	Overlook Medical Center	Summit	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

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