Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
This trial is active, not recruiting.
|Treatments||interview, survey instruments using web-based data collection system (wbdc) survey content|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Start date||May 2002|
|End date||May 2017|
|Trial size||1800 participants|
|Trial identifier||NCT00582842, 02-042|
The purpose of this study is to assess quality-of-life of men with prostate cancer. "Quality-of-life" means how you feel about your life as a result of your disease and its treatment. The investigators hope that this questionnaire will help show how prostate cancer treatments affect quality-of-life. It will help doctors and future patients to make better treatment choices. Some men may wish to have a more demanding treatment with a higher risk of harmful effects. Others may prefer a treatment that will have the smallest effect on their quality-of-life.
This questionnaire will help us measure these effects and decide which is the best treatment for a given patient.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Basking Ridge, NJ||Memoral Sloan Kettering Cancer Center||no longer recruiting|
|Commack, NY||Memorial Sloan Kettering Cancer Center @ Suffolk||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Rockville Centre, NY||Memorial Sloan Kettering at Mercy Medical Center||no longer recruiting|
|Sleepy Hollow, NY||Memoral Sloan Kettering Cancer Center@Phelps||no longer recruiting|
Assessment of temporal trends in HRQOL according to intervention group
time frame: study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment)and between 60 and 96 months.
Assessment of scale score differences between treatment groups
time frame: 3, 6, 9, 12, 15, 18, 24, 36, 48 months and between 60 and 96 months
Describe the quality of life of long-term survivors
time frame: 10 years post treatment
Male participants of any age.
Inclusion Criteria: - diagnosis of localized, untreated prostate cancer (clinical stages T1-3, Nx, M0) - ability to read the English language Exclusion criteria: - other cancer diagnosis for the past three years, except for non-melanoma skin cancer - prior chemotherapy within the last three years; radiation therapy to the pelvis or prior pelvic surgery within the past three years - prior neoadjuvant therapy, such as hormones (Bicalutamide use for less than or equal to 1 month would not constitute exclusion from study entry) For the cross-sectional component of the study, all patients identified to be free of disease at least ten years post -treatment will be considered eligible. Patients must have no clinical evidence of local, regional or distant recurrences. Patients must have the ability to read and understand English. Patients who received hormonal therapy will be eligible for the cross-sectional component of the study, but the duration of the hormonal therapy must be six months or less. the investigators have identified a cohort of patients who fit these criteria from our databases.
|Official title||Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer|
|Principal investigator||Peter Scardino, M.D.|
|Description||The intent of the protocol is to assess health-related quality-of-life (HRQOL) in men treated for localized prostate cancer with 1 of 6 established management alternatives: external (XRT)or interstitial radiotherapy (IRT), open radical prostatectomy (RP), laparoscopic radical prostatectomy (LRP), combined radiotherapy and brachytherapy (Combined RT) or watchful waiting (WW). HRQOL is an important aspect of any treatment for prostate cancer due to the beliefs by many that cancer control rates are similar across common modalities and HRQOL reduction from treatment is substantial (1-5). Therefore, HRQOL appears to occupy a central role in the decision making process related to treatment selection.|
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