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Trial record 16 of 167 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

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

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
Change History Complete list of historical versions of study NCT00966667 on ClinicalTrials.gov Archive Site
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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