Longitudinal Assessment of Health-Related Quality of Life in Men With Localized Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Interview; Behavioral: survey instruments using Web-Based Data Collection System (WBDC) survey content

• Registration Number: NCT00582842
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

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.

Study Timeline

• Study Start: 2002-05-14
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-28
• Status Verified: 2022-12
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1800

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Interview	Men with prostate cancer
2	survey instruments using Web-Based Data Collection System (WBDC) survey content	Men with prostate cancer

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	10 years post treatment	of prostate cancer following treatment

Trial Locations

Locations (5)

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