Clinical trial NCT00966667: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2009-08-27
Enrollment: 222
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Primary outcomes:
measure: Self-efficacy for changing physical activity and dietary practices
timeFrame: 3 yrs
measure: Outcome expectations with regard to physical activity and dietary practices
timeFrame: 3 yrs
measure: Behavioral self-regulation of physical activity and dietary practices
timeFrame: 3 yrs
measure: Perceived role of physical activity and dietary factors in causing colorectal cancer (CRC) and preventing recurrence (CRC illness representations)
timeFrame: 3 yrs
measure: Perceived risk of CRC recurrence
timeFrame: 3 yrs
measure: Cancer-related anxiety and worry about cancer recurrence (emotional representations of CRC)
timeFrame: 3 yrs
measure: Receipt of healthcare provider recommendations to alter physical activity and diet
timeFrame: 3 yrs
measure: Normative influences of family and friends
timeFrame: 3 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center in Edison
state: New Jersey
city: Freehold
country: United States
facility: Centrastate Healthcare System
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson University Hospital at Hamilton
state: New Jersey
city: Montclair
country: United States
facility: Mountainside Hospital
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peters University Hospital
state: New Jersey
city: Princeton
country: United States
facility: University Medical Center at Princeton
state: New Jersey
city: Somerville
country: United States
facility: Robert Wood Johnson University Hospital Somerset
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Elliot Coups, PhD
role: PRINCIPAL_INVESTIGATOR
References: