TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

NCT ID: NCT04936243

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-11-01

Brief Summary

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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

Detailed Description

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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

Conditions

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Breast Cancer Prostate Cancer Patient Engagement Patient Preference Patient Satisfaction

Keywords

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Breast Cancer Prostate Cancer Patient Engagement Patient Preference Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FOLLOW UP VISIT-TELEMEDICINE

Intervention Type BEHAVIORAL

Routine follow up care conducted remotely with video-conferencing tools

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.

Group Type EXPERIMENTAL

FOLLOW UP VISIT-FACE TO FACE

Intervention Type BEHAVIORAL

Routine follow up care conducted in person

Interventions

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FOLLOW UP VISIT-TELEMEDICINE

Routine follow up care conducted remotely with video-conferencing tools

Intervention Type BEHAVIORAL

FOLLOW UP VISIT-FACE TO FACE

Routine follow up care conducted in person

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christopher Manz, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Manz, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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21-192

Identifier Type: -

Identifier Source: org_study_id