TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Not Applicable

Completed

• Conditions: Prostate Cancer; Patient Preference; Patient Satisfaction; Breast Cancer; Patient Engagement
• Interventions: Behavioral: FOLLOW UP VISIT-TELEMEDICINE; Behavioral: FOLLOW UP VISIT-FACE TO FACE

• Registration Number: NCT04936243
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-18
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-23
• Study Start: 2021-08-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLLOW UP VISIT-TELEMEDICINE	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.
FOLLOW UP VISIT-FACE TO FACE	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.

Primary Outcome Measures

Name	Time	Method
Patient Experience Comparison	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

Secondary Outcome Measures

Name	Time	Method
Patient preference Comparison	Up to 6 months	Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care
Indirect Health Care Costs Comparison	Up to 6 months	Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits:
Health system use Comparison	Two weeks after study visit	Compare participant health system use relating to cancer diagnosis within two weeks after study visit
Clinician Preference	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
Clinician Experience Comparison	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
Symptom severity-prostate cancer patients Comparison	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

Trial Locations

Locations (2)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States