Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer
NCT ID: NCT00582842
Last Updated: 2022-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1800 participants
OBSERVATIONAL
2002-05-14
2022-12-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This questionnaire will help us measure these effects and decide which is the best treatment for a given patient.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Men with prostate cancer
Interview
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.
2
Men with prostate cancer
survey instruments using Web-Based Data Collection System (WBDC) survey content
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Interview
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.
survey instruments using Web-Based Data Collection System (WBDC) survey content
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ability to read the English language
Exclusion Criteria
* 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.
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Scardino, M.D.
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Memorial Sloan Kettering Cancer website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-042
Identifier Type: -
Identifier Source: org_study_id