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
1 other identifier
observational
88
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2022
Longer than P75 for all trials
1 active site
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
June 5, 2022
CompletedFirst Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 20, 2025
May 1, 2025
4 years
June 7, 2022
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
accrual number
1 year
patient satisfaction
using MSK Engage portal survey
1 week
Secondary Outcomes (1)
adherence to active surveillance
6 months
Other Outcomes (1)
Functional status
1 year
Study Arms (2)
Shared Medical Appointments
Usual Care Appointments
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Plan to undergo a prostate biopsy at this follow-up visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Behfar Ehdaie, MD, MPH
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 14, 2022
Study Start
June 5, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 20, 2025
Record last verified: 2025-05
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.