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A Study of a Side Effects and Resource Navigation Program for People With Cancer

NCT07646847 · Memorial Sloan Kettering Cancer Center
In plain English

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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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)
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-06-09
Estimated completion: 2029-06-09
Last updated: 2026-06-15
Interventions
Other: Immunotherapy CARE Program
Primary outcomes
  • Immune Checkpoint Inhibitors/ICI continuation (6 months)
Sponsor
Memorial Sloan Kettering Cancer Center · other
Contacts & investigators
ContactFrancesca Gany, MD, MS · contact · ganyf@mskcc.org · 646-888-8054
ContactNeil Shah, MBBS · contact · ShahN6@mskcc.org · 646-888-4239
InvestigatorFrancesca Gany, MD, MS · principal_investigator, Memorial Sloan Kettering Cancer Center
All locations (8)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
Harrison, New York, United States
City College of New York (Data Collection AND Specimen Analysis)Not Yet Recruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)Recruiting
Rockville Centre, New York, United States
A Study of a Side Effects and Resource Navigation Program for People With Cancer · TrialPath