TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936243
• Other study ID #: 21-192
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2022
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Patient Engagement
• Patient Preference
• Patient Satisfaction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• FOLLOW UP VISIT-TELEMEDICINE
Routine follow up care conducted remotely with video-conferencing tools
• FOLLOW UP VISIT-FACE TO FACE
Routine follow up care conducted in person

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

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