TIPOPS (Telemedicine vs In Person Oncology Patient Surveillance)

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction

Intervention / Treatment
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* Behavioral: FOLLOW UP VISIT-TELEMEDICINE
* Behavioral: FOLLOW UP VISIT-FACE TO FACE


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLLOW UP VISIT-TELEMEDICINE<br>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. | Behavioral: FOLLOW UP VISIT-TELEMEDICINE<br>* Routine follow up care conducted remotely with video-conferencing tools<br>|
| Experimental: FOLLOW UP VISIT-FACE TO FACE<br>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. | Behavioral: FOLLOW UP VISIT-FACE TO FACE<br>* Routine follow up care conducted in person<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference Comparison | Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care | Up to 6 months | 
| 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 | 
| Health system use Comparison | Compare participant health system use relating to cancer diagnosis within two weeks after study visit | Two weeks after study visit | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction