Formative Study of Tailored Survivor Health Promotion

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: One-time Questionnaire + Recorded Qualitative Interview

• Registration Number: NCT00825240
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-19
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Survivorship Study	One-time Questionnaire + Recorded Qualitative Interview	Survey of colorectal cancer patients within one year from treatment end.

Primary Outcome Measures

Name	Time	Method
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment	Qualitative data collection over 2 years

Trial Locations

Locations (3)

The Michael E. DeBakey VA Medical Center, Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Kelsey Research Foundation; 🇺🇸 Houston, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States