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OpenTrials
Completed

NCT Number: NCT00966667

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cooper Hospital/University Medical Center, Camden, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

Health Behaviors Among Individuals Diagnosed With Colorectal Cancer

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2009
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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