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NCT05540782 Clinical Trial

A Study of Cognitive Health in Survivors of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:
Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05540782
Other study ID # 22-223
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 8, 2022
Est. completion date September 8, 2025

Study information
Verified date January 2024
Source Memorial Sloan Kettering Cancer Center
Contact Kevin Liou
Phone 646-608-8559
Email liouk@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to collect information that may help the researchers understand the relationship between prostate cancer survivors' experiences of cancer-related cognitive dysfunction (CRCD) and their other conditions (co-morbid factors), including anxiety, depression, and insomnia. The researchers will also find out how additional things may contribute to CRCD, including social factors, the characteristics of participants' prostate cancer, and the type of cancer treatment or other medications they received.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 8, 2025
Est. primary completion date September 8, 2025
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - English-speaking - Age 18 years or older - History of histologically documented PC of any stage - No evidence of PC Disease Exclusion Criteria: - <1 month since completion of surgery, radiation, chemotherapy, or ADT - Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder - Score >10 indicative of dementia on Blessed Orientation Memory Concentration

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• PROMIS-SF v2.0 -Cognitive Function 8a
Patient-Reported Outcomes (PROs)

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center Suffolk - Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale 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 number of participants with co-morbid symptoms All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a. 1 year
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