Clinical trial NCT00825240: Formative Study of Tailored Survivor Health Promotion
Official title: Formative Study of Tailored Survivor Health Promotion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Cancer Survivorship Study
Questionnaires
Survivorship
Survivor Health
Health Promotion
Behavior Changes
Computer-assisted intervention program
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.

Brief summary: The overall goal of this study is to explore colorectal cancer patients' concerns and interest about their health and behavior changes post treatment. Investigators will conduct formative research, which includes qualitative interviews, to assess the issues that cancer survivors are willing to work on as they transition out of active treatment.

The specific aims are as follows:

Aim 1: Use qualitative interview methods to describe the taxonomy of domains health promotion and illness prevention behavior changes for which colorectal cancer survivors need new information, skills training and support.

Aim 2: Explore colorectal cancer patients' perceptions of their post treatment functional status.

Aim 3: Explore the impact of cancer, treatment, and co-morbidities on colorectal cancer patients' health goals and functional status.

Detailed description: Study Procedures:

If you agree to take part in this study, you will be asked to fill out a questionnaire about the your current health status, social support and goals.

After completing the questionnaire, you will have an interview with a research assistant. The interview will be audio recorded. You will be asked about goals you have for your health, what you are doing to reach those goals, resources you would like to receive, and challenges you faced since completing your treatment.

Your name and any of your other personal identifying information will not be linked to or collected with any of your responses. All audio tapes will be destroyed at the end of the study.

Length of Study :

The total time of participation for this study is about 45 minutes.

This is an investigational study. Up to 45 patients will be enrolled in this multicenter study. Up to 15 will be enrolled at M. D. Anderson.

Eligibility criteria: Inclusion Criteria:

1. Patient with Stage IIB or III colorectal cancer.
2. Men and women within 1 year of ending primary treatment for colorectal cancer.
3. Over 18 years of age.
4. Must be able to read and write English.
5. Must be able to understand and provide written informed consent.

Exclusion Criteria:

1) Patients who have had previous treatment for cancer before treatment at M.D. Anderson, Kelsey-Seybold, and the VA Medical Center.

Primary outcomes:
measure: Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment
timeFrame: Qualitative data collection over 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Kelsey Research Foundation
state: Texas
city: Houston
country: United States
facility: The Michael E. DeBakey VA Medical Center, Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Holly Holmes, MD
role: PRINCIPAL_INVESTIGATOR
References: