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

August 26, 2009
August 23, 2013
November 2009
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Self-efficacy for changing physical activity and dietary practices [ Designated as safety issue: No ]
  • Outcome expectations with regard to physical activity and dietary practices [ Designated as safety issue: No ]
  • Behavioral self-regulation of physical activity and dietary practices [ Designated as safety issue: No ]
  • Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations) [ Designated as safety issue: No ]
  • Perceived risk of CRC recurrence [ Designated as safety issue: No ]
  • Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC) [ Designated as safety issue: No ]
  • Receipt of healthcare provider recommendations to alter physical activity and diet [ Designated as safety issue: No ]
  • Normative influences of family and friends [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00966667 on ClinicalTrials.gov Archive Site
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Health Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer
Health Behaviors Among Individuals Diagnosed With Colorectal Cancer

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.

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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

colorectal cancer

Colorectal Cancer
Not Provided
cancer survivor
cancer survivor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
222
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00966667
130901, R21CA131611, P30CA072720, K07CA133100, CDR0000653167, 0220090178
No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Elliot Coups, PhD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP