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Brief Title: 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

INTRODUCTION

  • Org Study ID: 25-338
  • Secondary ID: N/A
  • NCT ID: NCT07646847
  • Sponsor: Memorial Sloan Kettering Cancer Center

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.

  • Overall Status
    Recruiting
  • Start Date
    September 14, 2026
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Immune Checkpoint Inhibitors/ICI continuation

Primary Outcome 1 - Timeframe: 6 months

CONDITION

  • Kidney Cancer
  • Bladder Cancer
  • Breast Cancer
  • Lung Cancer

ELIGIBILITY

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Francesca Gany, MD, MS

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Francesca Gany, MD, MS, Neil Shah, MBBS

Phone: 646-888-8054, 646-888-4239

Email: [email protected], [email protected]

LOCATION

Facility Status Contact
Facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York 11725
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054

Facility: Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York 11553
United States
Status: Recruiting Contact: Contact
Francesca Gany, MD, MS
646-888-8054