Supportive Care Delivered by Telemedicine to Cancer Patients at Home

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04136340

Collaborator

(none)

Enrollment

Location

Arms

47.2

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Supportive Care	Other: In-person in clinic follow-up visit Other: Telemedicine follow-up visit	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 24, 2019

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: In-person follow-up 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 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).
Experimental: Home Telemedicine follow-up	Other: Telemedicine follow-up visit 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.

Arm

Intervention/Treatment

Active Comparator: In-person follow-up

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

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).

Experimental: Home Telemedicine follow-up

Other: Telemedicine follow-up visit

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.

Outcome Measures

Primary Outcome Measures

Health-Related Quality of Life: FACT-G [Week 14]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

Principal Investigator: Judith Nelson, MD,JD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center

Publications

None provided.

Responsible Party:

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT04136340

Other Study ID Numbers:

19-382

First Posted:

Oct 23, 2019

Last Update Posted:

Jul 20, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Memorial Sloan Kettering Cancer Center

Telemedicine

Virtual Visits

19-382

Study Results

No Results Posted as of Jul 20, 2022