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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07646847
Enrollment
200
Registered
2026-06-15
Start date
2026-09-14
Completion date
2029-06-09
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Breast Cancer, Kidney Cancer, Lung Cancer

Keywords

Kidney Cancer, Bladder Cancer, Breast Cancer, Lung Cancer, Memorial Sloan Kettering Cancer Center, 25-338

Brief 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.

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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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 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)

Design outcomes

Primary

MeasureTime frameDescription
Immune Checkpoint Inhibitors/ICI continuation6 monthsParticipant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months

Countries

United States

Contacts

CONTACTFrancesca Gany, MD, MS
ganyf@mskcc.org646-888-8054
CONTACTNeil Shah, MBBS
ShahN6@mskcc.org646-888-4239
PRINCIPAL_INVESTIGATORFrancesca Gany, MD, MS

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026