Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | February 27, 2013 | ||||
| Start Date ICMJE | May 2002 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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). ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00582842 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Assessment of scale score differences between treatment groups [ Time Frame: 3, 6, 9, 12, 15, 18, 24, 36, 48 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer | ||||
| Official Title ICMJE | Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer | ||||
| Brief Summary | 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. |
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| Detailed 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1800 | ||||
| Estimated Completion Date | May 2014 | ||||
| Estimated Primary Completion Date | May 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Male | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00582842 | ||||
| Other Study ID Numbers ICMJE | 02-042 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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