A Study of Cognitive Health in Survivors of Prostate Cancer
Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)
1 other identifier
observational
200
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 8, 2026
October 9, 2025
October 1, 2025
4 years
September 9, 2022
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Survivors of Prostate Cancer
This is a cross-sectional study with a one-time data collection process and no subsequent follow-ups. If patients did not opt out of receiving study-specific text communications, they may also receive text messages with reminders about surveys and/or direct links to REDCap to complete the surveys. Text-based communications will be delivered using the secure, HIPAA-compliant Mosio texting platform developed for clinical research.
Interventions
Patient-Reported Outcomes (PROs)
Eligibility Criteria
Patients from Memorial Sloan Kettering Cancer Center (MSK) and the Ralph Lauren Center (RLC), an MSK-affiliated Harlem community clinic.
You may qualify if:
- English-speaking
- Age 18 years or older
- History of histologically documented PC of any stage
- No evidence of PC Disease
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center Suffolk - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Liou
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 15, 2022
Study Start
September 8, 2022
Primary Completion (Estimated)
September 8, 2026
Study Completion (Estimated)
September 8, 2026
Last Updated
October 9, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.