A Study of a Side Effects and Resource Navigation Program for People With Cancer
I CARE (Immunotherapy Cutaneous Adverse Events REsearch) - A Trial With Diverse Cancer Patients to Determine the Impact of SDoH and Side Effects Navigation Program on Treatment Continuation
1 other identifier
interventional
200
1 country
8
Brief Summary
The purpose of this study is to find out if the navigation program helps participants manage immunotherapy treatment better than usual care. Investigators will also look at how the navigation program impacts participants' quality of life. Investigators will measure quality of life by having participants complete questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
8 active sites
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
June 9, 2026
CompletedStudy Start
First participant enrolled
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 9, 2029
June 15, 2026
June 1, 2026
3 years
June 9, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune Checkpoint Inhibitors/ICI continuation
Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months
6 months
Study Arms (2)
I CARE Group
EXPERIMENTALImmunotherapy CARE Program
U&C Group
NO INTERVENTIONEnhanced Usual and Customary care and support (U\&C)
Interventions
For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation
Eligibility Criteria
You may qualify if:
- Documentation of Disease
- o Patient must have pathologically confirmed kidney, bladder, breast, or lung cancer (per EMR)
- Prior Treatment
- o Within two weeks (+/- 2 weeks) of starting PD-1 or PD(L)-1 immune checkpoint inhibitors as monotherapy or in combination with other therapies (per EMR)
- Age ≥ 18 (per EMR)
- Not Pregnant and Not Nursing (per self-report)
- At least one essential need (e.g., food, transportation, housing), as determined by the ICCAN Essential Needs Screener (per self-report)
- Lives in New York metro area, including Long Island, New Jersey, Connecticut, and Pennsylvania (per self-report)
- Can speak English or Spanish (per self-report)
- Has no significant psychiatric disturbance sufficient to preclude completion of the assessment measures, interview, or informed consent (i.e., acute psychiatric symptoms which require individual treatment) (per EMR, patient's care team, or study team)
- Has no presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patient's care team, or study team)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
City College of New York (Data Collection AND Specimen Analysis)
New York, New York, 10031, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesca Gany, MD, MS
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2026
First Posted
June 15, 2026
Study Start
June 9, 2026
Primary Completion (Estimated)
June 9, 2029
Study Completion (Estimated)
June 9, 2029
Last Updated
June 15, 2026
Record last verified: 2026-06
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 following one year after publication and for up to 36 months later. 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.