Supportive Care Delivered by Telemedicine to Cancer Patients at Home

Study Overview
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Brief Summary
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This study will test whether supportive care follow-up delivered to cancer patients at home by telemedicine (virtual medical visits using telecommunications technologies) is as effective as in-person supportive care visits in the clinic.

Detailed Description
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The protocol was developed and initially implemented when the standard of care for Supportive Care (and oncology) follow-up at MSK was in-person visiting and home telemedicine was only in an early stage of use at the institution. During the COVID-19 crisis, all outpatient Supportive Care visits and most oncology visits at MSK have been handled via telemedicine to protect patient (and staff) safety.

Official Title
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Virtual Visits by Supportive Care Specialists to Cancer Patients at Home: A Randomized Controlled Pilot Noninferiority Trial of Video Telemedicine

Conditions
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Cancer, Supportive Care

Intervention / Treatment
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* Other: In-person in clinic follow-up visit
* Other: Telemedicine follow-up visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older solid tumor of any type completed an initial in-person clinic visit (i.e. an IR/NV or AFX visit) at Rockefeller Outpatient Pavilion with Dr. Saldivar, Dr. Martin, Supportive Care physicians, or Andrea Dolan, a Supportive Care nurse practitioner planned for Supportive Care Service follow-up visits, but none yet completed enrolled on the MyMSK secure online patient portal and have access to the portal off site of MSK campuses resident of New York or New Jersey or Connecticut (clinicians may not be licensed in other states, as would be required for televisits to patients there) Exclusion Criteria: Patients and informal caregivers who cannot communicate with clinicians/respond to instruments in English without the use of an interpreter

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Noninferiority, randomized, controlled trial (RCT) in which all patients will meet with a supportive care specialist in-person for the initial clinic visit, and then receive follow-up supportive care visits either in-person at clinic or via home video telemedicine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person follow-up<br>Due to the COVID-19 pandemic, patients originally randomized to the in-person group received telemedicine visits. Thus, the researchers will expand our sample for these interviews to include patients who have completed at least 2 telemedicine follow-up visits whether they were originally randomized to the in-person group or the home telemedicine group. | Other: In-person in clinic follow-up visit<br>* Patient will be seen in-person (i.e. an IR/NV or AFX visit) in the clinic by a Supportive Care Specialist for at least 3 follow-up visits over 14 weeks. Any patients randomized to the in-person group who experience an extraordinary burden and/or are physically unable to attend their in-person visits will be able to be seen by their Supportive Care Service clinician via a home telemedicine visit (patients will return to their original group assignment if possible).<br>|
| Experimental: Home Telemedicine follow-up<br> | Other: Telemedicine follow-up visit<br>* i. Patients will be seen by video telemedicine at home by a Supportive Care Specialist for at least 3 follow-up visits over 14 weeks. ii. Patients will have access to a clickable link that will initiate a video telemedicine call to the clinician's office. The clinical team will be responsible for answering such calls and for ensuring the clinician and the patient connect and begin the actual visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life: FACT-G | will be used to quantify health-related quality of life at baseline and Week 14 after randomization. All items in the FACT-G use a 5-point scale (0=Not at all to 4=Very much) and the total score sums four subscales and ranges from 0-108 (higher=better QoL). Change in total score at Week 14 after randomization vs. baseline. | Week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Virtual Visits, 19-382