Clinical trial NCT04936243: TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)
Official title: A Randomized Control Trial of Telemedicine vs In Person Oncology Patient Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Patient Engagement
Patient Preference
Patient Satisfaction
Keywords: Breast Cancer
Prostate Cancer
Patient Engagement
Patient Preference
Patient Satisfaction
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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).

Primary outcomes:
measure: Patient Experience Comparison
timeFrame: Up to 6 months
Secondary outcomes:
measure: Patient preference Comparison
timeFrame: Up to 6 months
measure: Indirect Health Care Costs Comparison
timeFrame: Up to 6 months
measure: Health system use Comparison
timeFrame: Two weeks after study visit
measure: Clinician Experience Comparison
timeFrame: Up to 6 months
measure: Clinician Preference
timeFrame: Up to 6 months
measure: Symptom severity-prostate cancer patients Comparison
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Manz, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: