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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion Criteria:

- 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
I CARE Group 		Immunotherapy CARE Program
  • Other: 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
    Other names:
    • I CARE
No Intervention
U&C Group 		Enhanced Usual and Customary care and support (U&C)

Recruiting Locations

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

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

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

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

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

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

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

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Francesca Gany, MD, MS
646-888-8054
ganyf@mskcc.org