A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
Questionnaires:
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey
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.
No
Deborah A. Kuban, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Institutional Review Board
2007-0302
NCT00561444
November 2007
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |