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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

• Study Contact: Name: Sigrid Carlsson, MD, PhD, MPH; Phone Number: 646-422-4875; Email: carlssos@mskcc.org
• Study Contact Backup: Name: Behfar Ehdaie, MD, PhD; Phone Number: 646-422-4406

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Sigrid Carlsson, MD, PhD, MPH; Phone Number: 646-422-4875
      • Contact: Behfar Ehdaie, MD, MPH; Phone Number: 646-422-4406

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be recruited through two routes: 1) by physician invitation during routine Active Surveillance (AS) office visits or 2) by the physician's assistant or research team calling.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Shared Medical Appointments
Usual Care Appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accrual number		1 year
patient satisfaction	using MSK Engage portal survey	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adherence to active surveillance	the number who drop out of AS in the absence of disease progression	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Sigrid Carlsson, MD, PhD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Shared Medical Appointments; Individual Telemedicine Visits; 22-184
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 22-184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No