A Study of Telemedicine Shared Medical Appointments (SMAs) Versus Individual Telemedicine Visits for People With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Feasibility Study of Randomizing Patients to Telemedicine Shared Medical Appointments Versus Telemedicine Single Visits for Men With Prostate Cancer on Active Surveillance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05416996
• Other study ID #: 22-184
• Status: Active, not recruiting
• Start date: June 5, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• 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 see if a telemedicine group doctor's appointment is a practical (feasible) and acceptable method for following people with prostate cancer being managed with active surveillance when compared with the usual approach of individual telemedicine visits, which involve the participant visiting a doctor on their own. The researchers will compare the telemedicine group and individual visits by measuring on participant satisfaction and quality of life in each type of visit. Telemedicine is the use of secure video technology on a desktop computer, laptop, smartphone, or tablet to provide and receive healthcare from a distance.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A scheduled appointment for a subsequent Active Surveillance (AS) follow-up visit for management of localized prostate cancer

• Biopsy Gleason score 3+3=6 (Grade Group 1) or biopsy Gleason score 3+4=7 (Grade Group 2)

• Clinical T stage =T2B

• Access to a device with Zoom

• Ability to speak and understand English

Exclusion Criteria:

• Plan to undergo a prostate biopsy at this follow-up visit

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	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
Other	Functional status	These patient-reported outcomes are captured electronically and using validated questionnaires as part of the standard of care at MSK via MSK Engage. (anxiety, quality of life, urinary function, and erectile function)	1 year
Primary	accrual number		1 year
Primary	patient satisfaction	using MSK Engage portal survey	1 week
Secondary	adherence to active surveillance	the number who drop out of AS in the absence of disease progression	6 months

External Links

•   Memorial Sloan Kettering Cancer Center