Formative Study of Tailored Survivor Health Promotion

Colorectal Cancer Clinical Trial

Official title:

Formative Study of Tailored Survivor Health Promotion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825240
• Other study ID #: 2008-0296
• Status: Completed
• Phase: N/A
• First received: January 15, 2009
• Last updated: March 6, 2015
• Start date: December 2008
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• One-time Questionnaire + Recorded Qualitative Interview
One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.

Locations

Country	Name	City	State
United States	Kelsey Research Foundation	Houston	Texas
United States	The Michael E. DeBakey VA Medical Center, Baylor College of Medicine	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment		Qualitative data collection over 2 years	No

External Links

•   University of Texas MD Anderson Cancer Center Website