TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer; Patient Preference; Patient Satisfaction; Patient Engagement; Prostate Cancer

Treatments: Behavioral: FOLLOW UP VISIT-FACE TO FACE; Behavioral: FOLLOW UP VISIT-TELEMEDICINE

Study type: Interventional

Funder types: Other

Identifiers

NCT04936243

21-192

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

FOLLOW UP VISIT-TELEMEDICINE

Experimental group

Description:

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.

Treatment:

Behavioral: FOLLOW UP VISIT-TELEMEDICINE

FOLLOW UP VISIT-FACE TO FACE

Experimental group

Description:

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.

Treatment:

Behavioral: FOLLOW UP VISIT-FACE TO FACE