Breast Cancer, Patient Engagement, Patient Preference, Patient Satisfaction, Prostate Cancer
Conditions
Keywords
Breast Cancer, Prostate Cancer, Patient Engagement, Patient Preference, Patient Satisfaction
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
Interventions
BEHAVIORALFOLLOW UP VISIT-TELEMEDICINE
Routine follow up care conducted remotely with video-conferencing tools
BEHAVIORALFOLLOW UP VISIT-FACE TO FACE
Routine follow up care conducted in person
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience Comparison | Up to 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Indirect Health Care Costs Comparison | Up to 6 months | Compare patient reported indirect healthcare costs for Telemedicine (TM) versus Face to Face (F2F) follow up visits: |
| Health system use Comparison | Two weeks after study visit | Compare participant health system use relating to cancer diagnosis within two weeks after study visit |
| Patient preference Comparison | Up to 6 months | Compare patient preferences for Telemedicine (TM) versus Face to Face (F2F) visits for ongoing cancer care |
| Clinician Preference | Up to 6 months | 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 |
| Symptom severity-prostate cancer patients Comparison | Up to 6 months | 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 |
| Clinician Experience Comparison | Up to 6 months | 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 |
Countries
United States
Outcome results
None listed