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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00966667
First received: August 26, 2009
Last updated: August 23, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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 Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Study Population

colorectal cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966667

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Elliot Coups, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of 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: August 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of 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 September 18, 2014