A Study of a Side Effects and Resource Navigation Program for People With Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunotherapy CARE Program.
- Who it may be relevant to
- Registry conditions: Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Immunotherapy CARE Program
For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation
Primary outcome measures
- Immune Checkpoint Inhibitors/ICI continuation [Time frame: 6 months]
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 three weeks (+/- 3 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 8 centers
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
- City College of New York (Data Collection AND Specimen Analysis) — New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre
Identifiers
NCT: NCT07646847 · 25-338