Recruiting

Navigation Program

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07646847

Conditions

Kidney Cancer

Bladder Cancer

Breast Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immunotherapy CARE Program

Study Details

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.

Conditions

Kidney Cancer

Bladder Cancer

Breast Cancer

Lung Cancer

Study ID

NCT07646847

Start date

Sep 14, 2026

Status verified date

Jul, 2026

Completion date

Jun 9, 2029

Anticipated

Primary completion date

Jun 9, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: I CARE Group

Immunotherapy CARE Program

no intervention: U&C Group

Enhanced Usual and Customary care and support (U\&C)

Interventions

Immunotherapy CARE Program

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

Primary outcome measure

  • Immune Checkpoint Inhibitors/ICI continuation [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Francesca Gany, MD, MS

646-888-8054ganyf@mskcc.org

Neil Shah, MBBS

646-888-4239ShahN6@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Francesca Gany, MD, MS

646-888-8054

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Francesca Gany, MD, MS

646-888-8054

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-31.