CancerNCT04136340
Supportive Care Delivered by Telemedicine to Cancer Patients at Home
A study testing In-person in clinic follow-up visit and Telemedicine follow-up visit in people with Cancer and Supportive Care, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Supportive Care
- What is being tested?
- In-person in clinic follow-up visit and Telemedicine follow-up visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2019to 3 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients and informal caregivers who cannot communicate with clinicians/respond to instruments in English without the use of an interpreter
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Virtual Visits by Supportive Care Specialists to Cancer Patients at Home: A Randomized Controlled Pilot Noninferiority Trial of Video Telemedicine
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.
Read the 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.
- Conditions
- Cancer, Supportive Care
- Being tested
- In-person in clinic follow-up visit, Telemedicine follow-up visit
- Keywords
- Telemedicine, Virtual Visits, 19-382
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person in clinic follow-up visitOther
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).
Telemedicine follow-up visitOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: In-person in clinic follow-up visit |
| Home Telemedicine follow-up | Experimental | Not described Receives: Other: Telemedicine follow-up visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start24 Oct 2019
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Nelson, MD,JD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136340
- Sponsor's protocol ID
- 19-382
- Status last verified
- Jul 2025
- First submitted
- 21 Oct 2019
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Visits by Supportive Care Specialists to Cancer Patients at Home: A Randomized Controlled Pilot Noninferiority Trial of Video Telemedicine
- ClinicalTrials.gov ID
- NCT04136340
- Acronym / sponsor ID
- 19-382
- Conditions
- Cancer, Supportive Care
- Keywords
- Telemedicine, Virtual Visits, 19-382
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-person follow-up | Active comparator | Other: In-person in clinic follow-up visitDue 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. |
| Home Telemedicine follow-up | Experimental | Other: Telemedicine follow-up visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients and informal caregivers who cannot communicate with clinicians/respond to instruments in English without the use of an interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person in clinic follow-up visitPatient 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). | Other | In-person follow-up |
| Telemedicine follow-up visiti. 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. | Other | Home Telemedicine follow-up |
Primary outcome
Health-Related Quality of Life: FACT-G
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Nelson, MD,JD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person in clinic follow-up visit and Telemedicine follow-up visit in people with Cancer and Supportive Care, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life: FACT-G (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.