Breast Cancer Clinical Trial
TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)
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
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
Eligibility Criteria
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).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02115, United States
How clear is this clinincal trial information?