NCT04136340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

5.7 years

First QC Date

October 21, 2019

Last Update Submit

July 7, 2025

Conditions

Keywords

TelemedicineVirtual Visits19-382

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

In-person follow-up

ACTIVE COMPARATOR

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

Home Telemedicine follow-up

EXPERIMENTAL
Other: Telemedicine follow-up visit

Interventions

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).

In-person follow-up

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.

Home Telemedicine follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients and informal caregivers who cannot communicate with clinicians/respond to instruments in English without the use of an interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Judith Nelson, MD,JD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

October 24, 2019

Primary Completion

July 3, 2025

Study Completion

July 3, 2025

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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