Telemedicine for Oncology Patient Surveillance, the TIPOPS Study

Status: closed to accrual

This clinical trial compares telemedicine and face-to-face visits in conducting follow up care for patients with breast or prostate cancer. Telemedicine visits are visits between a patient and their clinician (physician, nurse practitioner or physician assistant) that take place using the telephone or computer with or without video technology. Telemedicine visits enable patients to have follow up visits without needing to travel to the clinic. However, telemedicine visits do not allow for a comprehensive in person physical exam. Information learned from this research study may provide more information about cancer patients’ experiences and preferences with telemedicine, and help the study doctors compare ways to provide efficient and high quality care for patients with cancer.

Inclusion Criteria

Early-stage breast cancer defined as stages 0-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)

PRIMARY OBJECTIVE:

I. To 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 OBJECTIVES:

I. To compare patient preferences for TM versus (vs.) F2F visits for ongoing cancer care.

II. To compare patient reported indirect healthcare costs for TM vs. F2F follow up visits:

IIa. Time spent waiting for clinician.

IIb. Door to door travel time for visit.

IIc. Time taken off work.

IId. Visit associated out of pocket costs.

III. To compare participant health system use (telephone encounters, Patient Gateway messages, inpatient, outpatient, emergency department, imaging, laboratory) relating to cancer diagnosis within two weeks after study visit.

IV. To compare the clinician experience with TM versus F2F for a one-time surveillance follow up visit for breast or prostate cancer care.

V. To understand cancer clinicians’ attitudes and preferences 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.

VI. To 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. (Prostate cancer patients only)

OUTLINE: Patients attend a standard of care face-to-face follow up visit and complete a survey over 10 minutes at baseline. Patients are then randomized to 1 of 2 arms.

ARM A: Patients attend a telemedicine follow up visit and complete a survey over 10 minutes at 6 months.

ARM B: Patients attend a face-to-face follow up visit and complete a survey over 10 minutes at 6 months.

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Telemedicine for Oncology Patient Surveillance, the TIPOPS Study

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help