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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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
City College of New York (Data Collection AND Specimen Analysis)
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITING
Rockville Centre
Contact Information
Primary
Francesca Gany, MD, MS
ganyf@mskcc.org
646-888-8054
Backup
Neil Shah, MBBS
ShahN6@mskcc.org
646-888-4239
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2029-06-09
Participants
Target number of participants: 200
Treatments
Experimental: I CARE Group
Immunotherapy CARE Program
No_intervention: U&C Group
Enhanced Usual and Customary care and support (U\&C)
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov