Quality of Life Study for Prostate Cancer Patients
The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients|
- QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey [ Time Frame: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years. ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Quality of Life Study
Prostate cancer patients
Questionnaires taking 20 minutes to complete.
Other Name: Survey
You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.
If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.
If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.
If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.
For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.
Length of Study:
All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.
This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561444
|Contact: Deborah A. Kuban, MD||713-563-7382|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Deborah A. Kuban, MD|
|Principal Investigator:||Deborah A. Kuban, MD||M.D. Anderson Cancer Center|