Quality of Life Study for Prostate Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00561444|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2007
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Behavioral: Questionnaire|
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.
|Study Type :||Observational|
|Actual Enrollment :||1051 participants|
|Official Title:||A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients|
|Actual Study Start Date :||November 14, 2007|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Quality of Life Study
Prostate cancer patients
Questionnaires taking 20 minutes to complete.
Other Name: Survey
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561444
|United States, New Jersey|
|MD Anderson at Cooper|
|Voorhees, New Jersey, United States, 08043|
|United States, New Mexico|
|MD Anderson Cancer Center at Albuquerque|
|Albuquerque, New Mexico, United States, 87110|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Deborah A. Kuban, MD||M.D. Anderson Cancer Center|