Formative Study of Tailored Survivor Health Promotion

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00825240
First received: January 15, 2009
Last updated: January 27, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 2015 (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
Study Population

Stage IIB or III Colorectal cancer patients over 18 years of age ending cancer treatment or have completed cancer treatment.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825240

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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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 27, 2014
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 August 21, 2014