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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

NCT ID: NCT07646847Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-06-15

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.

Arms & interventions

  • OtherImmunotherapy CARE Program

    For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation

Outcome measures

Primary

  • Immune Checkpoint Inhibitors/ICI continuation

    Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
Francesca Gany, MD, MS · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Francesca Gany, MD, MS · Contact

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
Francesca Gany, MD, MS · Contact

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, 11725

Recruiting
Francesca Gany, MD, MS · Contact

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Francesca Gany, MD, MS · Contact

City College of New York (Data Collection AND Specimen Analysis)

New York, New York, 10031

Not Yet Recruiting
Bao Vuong, PhD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Francesca Gany, MD, MS · Contact

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553

Recruiting
Francesca Gany, MD, MS · Contact