- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825240
Formative Study of Tailored Survivor Health Promotion
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Houston, Texas, United States, 77005
- Kelsey Research Foundation
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Houston, Texas, United States, 77030
- The Michael E. DeBakey VA Medical Center, Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient with Stage IIB or III colorectal cancer.
- Men and women within 1 year of ending primary treatment for colorectal cancer.
- Over 18 years of age.
- Must be able to read and write English.
- 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer Survivorship Study
Survey of colorectal cancer patients within one year from treatment end.
|
One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment
Time Frame: Qualitative data collection over 2 years
|
Qualitative data collection over 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Holly Holmes, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-0296
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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