Formative Study of Tailored Survivor Health Promotion
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Behavioral: One-time Questionnaire + Recorded Qualitative Interview |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | Formative Study of Tailored Survivor Health Promotion |
- Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment [ Time Frame: Qualitative data collection over 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cancer Survivorship Study
Survey of colorectal cancer patients within one year from treatment end.
|
Behavioral: One-time Questionnaire + Recorded Qualitative Interview
One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.
Other Name: surveys
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.
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.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| The Michael E. DeBakey VA Medical Center, Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Kelsey Research Foundation | |
| Houston, Texas, United States, 77005 | |
| Principal Investigator: | Holly Holmes, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00825240 History of Changes |
| Other Study ID Numbers: | 2008-0296 |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Colorectal Cancer Cancer Survivorship Study Questionnaires Survivorship |
Survivor Health Health Promotion Behavior Changes Computer-assisted intervention program |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013