NCT05416996

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2022Jun 2026

Study Start

First participant enrolled

June 5, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

June 7, 2022

Last Update Submit

May 19, 2025

Conditions

Keywords

TelemedicineShared Medical AppointmentsIndividual Telemedicine Visits22-184

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

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Behfar Ehdaie, MD, MPH

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

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.

Locations