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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582842
• Other study ID #: 02-042
• Status: Completed
• Start date: May 14, 2002
• Est. completion date: December 21, 2022

Study information

• Verified date: December 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of scale score differences between treatment groups		3, 6, 9, 12, 15, 18, 24, 36, 48 months and between 60 and 96 months
Secondary	Describe the quality of life of long-term survivors	of prostate cancer following treatment	10 years post treatment

External Links

•   Memorial Sloan Kettering Cancer website