Side Effects and Resource Navigation Program for Cancer Patients
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
Run by Memorial Sloan Kettering Cancer Center · NCT07646847 · Data updated 2026-11-12
This program tests whether a navigation service helps adults with kidney, bladder, breast, or lung cancer manage immunotherapy better than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Status | Recruiting |
| Started | June 9, 2026 |
| Main results expected | June 9, 2029 |
| Study ends | June 9, 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07646847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with kidney, bladder, breast, or lung cancer starting PD-1/PD-L1 therapy, who have essential needs and meet SDOH criteria, and reside in the NY metro area.
✕Probably not a fit
Patients without identified essential needs or who do not start immunotherapy within the specified window may not experience the program’s benefits and may receive standard care.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study evaluates a dedicated immunotherapy CARE Program to support patients starting PD-1 or PD-L1 inhibitors, aiming to improve treatment management and quality of life. Participants are adults in the New York metro region with specific cancers and at least one essential need, who begin immunotherapy within a defined timeframe. Outcomes include self-reported quality of life and other participant-reported experiences collected through questionnaires. The program is delivered within Memorial Sloan Kettering locations in New Jersey and surrounding areas. The trial does not have a listed phase and uses an interventional design.
Why it matters
Potential benefit: If successful, participants may experience better symptom management, smoother treatment navigation, and improved quality of life during immunotherapy.
How similar studies have gone: Previous navigation and support programs in oncology have shown improvements in care coordination and patient-reported outcomes, though results vary by setting and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documentation of Disease o Patient must have pathologically confirmed kidney, bladder, breast, gastrointestinal 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) * Screens positive on SDOH screening tool, referred by the clinical team through traditional screening tools for SDOH assistance orand demonstrates financial need per MSK guidelines (up to 500% of the federal poverty limit) (per EMR or 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 serious life-threatening allergies to tape or adhesives (per EMR or 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)
Where it's running
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States Recruiting
Show 2 more locations
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Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States Recruiting -
City College of New York (Data Collection AND Specimen Analysis)
New York, New York, United States Not yet recruiting
Study contacts
- Principal investigator: Francesca Gany, MD, MS — Memorial Sloan Kettering Cancer Center
- Study coordinator: Francesca Gany, MD, MS
- Email: ganyf@mskcc.org
- Phone: 646-888-8054
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.