TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

December 19, 2022 updated by: Christopher Manz, MD, Dana-Farber Cancer Institute

A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance

This research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective randomized trial of telemedicine (TM) versus face-to-face (F2F) visits for follow up care of patients with either early-stage breast or prostate cancer.

This study does not involve investigational drugs or devices but does involve survey data collection from participants about their experiences of care.

After an initial in-person routine visit, participants will be randomly assigned to either telemedicine or face-to-face care delivery for their next routine visit.

It is anticipated participants will be in the study for about 6 months depending on the timing of their routine care appointments.

It is expected that 360 people will take part in this research study

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For breast cancer participants: Early-stage breast cancer defined as Stages I-IIIA at diagnosis or localized prostate cancer defined as Stages I-III
  • For breast cancer participants: participant has completed definitive treatment for early stage breast cancer including surgery, radiation, chemotherapy, anti-HER2 antibody treatment. Participant may or may not be taking oral anti-estrogen treatment such as tamoxifen or an aromatase inhibitor
  • For prostate cancer participants: participant is on active surveillance or has undergone definitive surgery for localized prostate cancer
  • Participant is on a surveillance follow up visit schedule occurring at every three to seven month intervals
  • Willingness and ability to use Patient Gateway portal
  • Participant has access to an electronic device that can support a video and audio virtual visit platform (for example, laptop computer, desktop computer, smart phone)
  • Participants can be women or men
  • Age ≥ 18 years

Exclusion Criteria:

  • Patients whose next visit requires cytotoxic chemotherapy, radiation therapy, anti-HER2 antibody therapy or investigational cancer agents are ineligible
  • Patients with distant metastatic breast cancer
  • Patients with locally advanced or metastatic prostate cancer
  • Patients treated by radiation therapy for prostate cancer
  • Patients whose next visit requires a prostate biopsy
  • Prisoners
  • Non-English speaking patients (non-English speaking patients will be excluded from the trial given the challenges of delivering telemedicine with the use of medical interpreters. There are also logistical challenges in obtaining the study endpoints, which are largely survey based, with non-English speakers as well as the possibility that study endpoints will be influenced by the presence of a medical interpreter during a visit).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FOLLOW UP VISIT-TELEMEDICINE
After initial in-person routine followup care, participants will be randomly assigned to receive telemedicine care delivery for their subsequent follow up appointment. Participants will complete a survey after each visit.
Behavioral: FOLLOW UP VISIT-TELEMEDICINE
Routine follow up care conducted remotely with video-conferencing tools
Experimental: FOLLOW UP VISIT-FACE TO FACE
After initial in-person routine followup care, participants will be randomly assigned to receive face-to-face care delivery for their subsequent follow up appointment. Participants will complete a survey after each visit.
Behavioral: FOLLOW UP VISIT-FACE TO FACE
Routine follow up care conducted in person

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experience Comparison
Time Frame: Up to 6 months
Compare early-stage breast and early stage prostate cancer patients' experiences with a one-time Telemedicine (TM) versus Face to Face (F2F) follow up visit for routine oncologic surveillance
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient preference Comparison
Time Frame: Up to 6 months
Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care
Up to 6 months
Indirect Health Care Costs Comparison
Time Frame: Up to 6 months
Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:
Up to 6 months
Health system use Comparison
Time Frame: Two weeks after study visit
Compare participant health system use relating to cancer diagnosis within two weeks after study visit
Two weeks after study visit
Clinician Experience Comparison
Time Frame: Up to 6 months
Compare the clinician experience with Telemedicine (TM) versus Face to Face (F2F) for a one-time surveillance follow up visit for breast or prostate cancer care
Up to 6 months
Clinician Preference
Time Frame: Up to 6 months
Assessing clinician preference regarding the appropriate use of telemedicine visits for the follow-up of early stage cancer patients who have completed early active therapy (e.g., surgery, radiation and/or chemotherapy) or are under surveillance
Up to 6 months
Symptom severity-prostate cancer patients Comparison
Time Frame: Up to 6 months
Compare patient reported erectile dysfunction and urinary symptoms after undergoing radical prostatectomy between patients who have a TM follow up visit vs. a F2F follow up visit
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Christopher Manz, MD, MSHP, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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