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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Men with prostate cancer |
| |
| 2 | Men with prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Behavioral | The phone interview will consist of the following items from the follow up questionnaire; 14, 16, 20, 32, 33, 46, 47, 60, and 65. An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of temporal trends in HRQOL according to intervention group | study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment)and between 60 and 96 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of scale score differences between treatment groups | 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 | of prostate cancer following treatment |
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Inclusion Criteria:
Exclusion criteria:
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.
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All eligible MSKCC patients (including patients from the regional network sites: Commack, Basking Ridge, Rockville Centre and Sleepy Hollow) will be approached by consenting professionals and invited to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Scardino, M.D. | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer website | View source |
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|
| survey instruments using Web-Based Data Collection System (WBDC) survey content | Behavioral | The content of the WBDC questionnaire will be similar to the paper form, no alteration in the wording, the order, or the formate of the items will be done. In addition, at the time of each outpatient clinic visit to MSKCC, these subjects will be able to login to WBDC using a computer located in the patient waiting-area, and enter their responses to the different items of the questionnaire if their clinic visit corresponds to any of the study time points 3, 6, 9, 12, 15, 18, 24, 36, and 48 following treatment). An additional component of this study would be dispensing the HRQOL tool to long-term survivors 10 years or greater after the completion of therapy. The long term QoL study will be a cross-sectional assessment measuring HRQOL in prostate cancer survivors, free of disease at least ten years post-treatment. Patients will complete a questionnaire by selfreport focusing on assessment of HRQOL. |
|
| 10 years post treatment |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memoral Sloan Kettering Cancer Center@Phelps | Sleepy Hollow | New York | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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