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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:
Collaborators:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00966667
First received: August 26, 2009
Last updated: September 26, 2014
Last verified: September 2014
  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 2015
Estimated Primary Completion Date: December 2014 (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
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
JFK Medical Center in Edison
Edison, New Jersey, United States, 08818
Centrastate Healthcare System
Freehold, New Jersey, United States, 07728
Robert Wood Johnson University Hospital at Hamilton
Hamilton, New Jersey, United States, 08690
Mountainside Hospital
Montclair, New Jersey, United States, 07042
Morristown Medical Center
Morristown, New Jersey, United States, 07962
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
Saint Peters University Hospital
New Brunswick, New Jersey, United States, 08903
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States, 07901
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers Cancer Institute 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
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: September 26, 2014
Health Authority: United States: Institutional Review Board
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014