RecruitingNot ApplicableNCT07646847

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

Jun 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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)

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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


Locations(8)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

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

New York, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07646847


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