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

January 15, 2009
January 27, 2014
December 2008
December 2015   (final data collection date for primary outcome measure)
Colorectal Cancer Patients' Concerns + Behavior Changes Post Treatment [ Time Frame: Qualitative data collection over 2 years ] [ Designated as safety issue: No ]
To learn the concerns and issues that colorectal cancer patients have when ending treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00825240 on ClinicalTrials.gov Archive Site
Not Provided
To study health goals used to prevent the return of cancer and improve quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Formative Study of Tailored Survivor Health Promotion
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 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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Colorectal Cancer
Behavioral: One-time Questionnaire + Recorded Qualitative Interview
One-time questionnaire + recorded qualitative interview, approximately 45 minutes total.
Other Name: surveys
Cancer Survivorship Study
Survey of colorectal cancer patients within one year from treatment end.
Intervention: Behavioral: One-time Questionnaire + Recorded Qualitative Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
Not Provided
December 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00825240
2008-0296
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Holly Holmes, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP