A Study of Cognitive Health in Survivors of Prostate Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05540782
• Collaborator: (none)
• Enrollment: 200
• Locations: 7
• Anticipated Duration (Months): 24
• Patients Per Site: 28.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Survivorship	Behavioral: PROMIS-SF v2.0 -Cognitive Function 8a

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Prostate Cancer Survivorship and Cognitive Health (PRO-HEALTH)
• Actual Study Start Date: Sep 8, 2022
• Anticipated Primary Completion Date: Sep 8, 2024
• Anticipated Study Completion Date: Sep 8, 2024

Arms and Interventions

Arm	Intervention/Treatment
Survivors of Prostate Cancer	Behavioral: PROMIS-SF v2.0 -Cognitive Function 8a; Patient-Reported Outcomes (PROs)

Outcome Measures

Primary Outcome Measures

1. number of participants with co-morbid symptoms [1 year]

   All participants will be evaluable as long as they have completed the PROMIS-SF v2.0 - Cognitive Function 8a.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male

Inclusion Criteria:

• English-speaking

• Age 18 years or older

• History of histologically documented PC of any stage

• Undetectable PSA levels

Exclusion Criteria:

• <1 month since completion of surgery, radiation, chemotherapy, or ADT

• Greater than 10 years since PC diagnosis

• Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder

• Score >10 indicative of dementia on Blessed Orientation Memory Concentration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center Suffolk - Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Kevin Liou, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05540782
• Other Study ID Numbers: 22-223
• First Posted: Sep 15, 2022
• Last Update Posted: Sep 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Cognitive health; Quality of Life; 22-223
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Sep 15, 2022