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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00966667
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 222 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Health Behaviors Among Individuals Diagnosed With Colorectal Cancer
Study Start Date : November 2009
Actual Primary Completion Date : August 7, 2019
Actual Study Completion Date : August 7, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
cancer survivor
cancer survivor


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

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966667


Locations
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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
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Saint Peters University Hospital
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
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Elliot Coups, PhD Rutgers Cancer Institute of New Jersey
More Information
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Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: 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 )
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases