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

• ClinicalTrials.gov Identifier: NCT00966667
• Recruitment Status: Completed
• First Posted: August 27, 2009
• Last Update Posted: September 10, 2019
• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey
• Information provided by (Responsible Party): Rutgers, The State University of New Jersey

Tracking Information

• First Submitted Date: August 26, 2009
• First Posted Date: August 27, 2009
• Last Update Posted Date: September 10, 2019
• Study Start Date: November 2009
• Actual Primary Completion Date: August 7, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2011)

• 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 ]

Original Primary Outcome Measures (submitted: August 26, 2009)

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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
• Official Title: Health Behaviors Among Individuals Diagnosed With Colorectal Cancer

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.

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 Type: Observational
• Study Design: Observational Model: Ecologic or Community; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: colorectal cancer
• Condition: Colorectal Cancer
• Intervention: Not Provided

Study Groups/Cohorts

cancer survivor

cancer survivor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: August 26, 2009): 222
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 7, 2019
• Actual Primary Completion Date: August 7, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00966667
• Other Study ID Numbers: 130901; R21CA131611 ( U.S. NIH Grant/Contract ); P30CA072720 ( U.S. NIH Grant/Contract ); K07CA133100 ( U.S. NIH Grant/Contract ); CDR0000653167 ( Other Identifier: NIH ); 0220090178 ( Other Identifier: IRB )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Rutgers, The State University of New Jersey
• Study Sponsor: Rutgers, The State University of New Jersey

Collaborators

• National Cancer Institute (NCI)
• Rutgers Cancer Institute of New Jersey

Investigators

• Principal Investigator: Elliot Coups, PhD; Rutgers Cancer Institute of New Jersey

• PRS Account: Rutgers, The State University of New Jersey
• Verification Date: September 2019