Recruiting

NCT Number: NCT07646847

A Study of a Side Effects and Resource Navigation Program for People With Cancer

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.

Recruiting

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Key information

Conditions

Kidney Cancer Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immunotherapy CARE Program

Other

For participants assigned to the I CARE arm, CCNY staff will assist in monthly essential needs and side effects/symptom reporting navigation

Other names: I CARE

Primary outcomes

Immune Checkpoint Inhibitors/ICI continuation

Time frame: 6 months

Participant ICI appointment and treatment adherence will be documented through chart abstraction (research staff EMR review) at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Gany, MD, MS

CONTACT

[email protected]

646-888-8054

Neil Shah, MBBS

CONTACT

[email protected]

646-888-4239

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jun 15, 2026
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting