Impact of ICCAN on Cancer Treatment Completion and Quality of Life

A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life

The purpose of this study is to see if the ICCAN program is working, and to compare the ICCAN program to the standard hospital services provided in New York City hospitals, like meeting with a Social Worker or a Patient Navigator (a person who provides personal hospital guidance).

Study Overview

• Status: Recruiting
• Conditions: Cancer Patients
• Intervention / Treatment: Behavioral: The Integrated Cancer Care Access Network (ICCAN); Behavioral: Usual and Customary Group (U&C)

• Study Type: Observational
• Enrollment (Estimated): 347

Contacts and Locations

• Study Contact: Name: Francesca Gany, MD, MS; Phone Number: 646-888-8054
• Study Contact Backup: Name: Jennifer Leng, MD, MPH; Phone Number: 646-888-4243

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Francesca Gany, MD, MS; Phone Number: 646-888-8054
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Fransecsa Gany, MD, MS; Phone Number: 646-888-8054
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Francesca Gany, MD, MS; Phone Number: 646-888-8054
  • New York
    • Brooklyn, New York, United States, 11220
      • Active, not recruiting
      • Lutheran Medical Center
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
      • Contact: Francesca Gany, MD, MS; Phone Number: 646-888-8054
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Francesca Gany, MD, MS; Phone Number: 646-888-8054
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Francesca Gany, MD, MS; Phone Number: 646-888-8054
      • Contact: Jennifer Leng, MD, MPH; Phone Number: 646-888-4243
      • Principal Investigator: Francesca Gany, MD, MS
    • New York, New York, United States, 10035
      • Recruiting
      • Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
      • Contact: Francesca Gany, MD; Phone Number: 646-888-8054
    • New York, New York, United States, 10031
      • Recruiting
      • City College of New York (Data Collection AND Data Analysis)
      • Contact: Adriana Espinosa, MD; Phone Number: 212-650-8404; Email: aespinosa@ccny.cuny.edu
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Franscesca Gany, MD, MS; Phone Number: 646-888-8054
    • The Bronx, New York, United States
      • Active, not recruiting
      • Lincoln Hospital and Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Eligible cancer patients will be recruited in person by multilingual ICCAN Clinical Research Coordinators for participation in the study at Ralph Lauren Center for Cancer Care and Prevention (RLCCP), Lincoln Hospital (LH) and Lutheran Medical Center (LMC). In the event that MSK staff is not present when an eligible patient is identified. Refinement and Pilot RCT participants will be recruited through MSK Manhattan and OneMSK regional sites's.

Description

Participant Inclusion Criteria:

Patient is eligible if he/she is

• fluent in English, Spanish, or Mandarin
• between the ages of 21-80 years old
• cancer patients currently receiving chemotherapy (started within the past month) and/or radiation therapy (started within the past week), or
• scheduled to begin chemotherapy and/or radiation therapy within the next 2 months (excluding surgery only patients)
• planning on remaining in the area for at least 1 year

Clinician is eligible if he/she:

• Has an MD or DO degree
• Is the treating physician providing care to a patient enrolled to the study

ICCAN-IO Phase 1: Refinement, participant is eligible if he/she per EMR or self-report:

• Is 18 - 85 years of age
• Has unresectable locally advanced, locally recurrent unresectable, metastatic, or high risk/early stage TNBC or stage I-IV lung cancer
• Eligible for FDA approved immunotherapy in the NYC metropolitan area (per self-report or per MSK patient EMR records).
• Is treated in the NY metropolitan area
• Self-identifies as Black or Hispanic, and/or is low-SES (low SES will be defined as household income < 200% of federal poverty level)
• Has English or Spanish proficiency
• Agrees to be audio-recorded

ICCAN-IO Phase 2: Pilot RCT, participant is eligible if he/she per EMR or self-report:

• Is 18 - 85 years of age
• Has stage II-III TNBC
• Treated at MSK Manhattan or OneMSK regional sites
• Self identifies as Black or Hispanic, and/or is low SES (low SES will be defined as household income < 200% of federal poverty level)
• Has English or Spanish proficiency
• Agrees to be audio-recorded

ICCAN-IO process evaluation study team participants only:

• Staff member who serves as an Access Facilitator
• Agrees to be audio-recorded

Participant Exclusion Criteria:

Patient is ineligible is he/she is:

• Presence of untreated psychiatric disturbance (i.e. acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) verified by medical record sufficient to preclude completion of the assessment measures, interview or informed consent

ICCAN-IO Phase 1: Refinement, participant is ineligible if he/she per EMR or self-report:

• Presence of untreated psychiatric disturbance (e.g., acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude completion of the assessment measures, interview or informed consent
• Participants or family members who are participating in MSK IHCD studies related to social determinants of health

ICCAN-IO Phase 2: Pilot RCT, participant is ineligible if he/she per EMR or self-report:

• Presence of untreated psychiatric disturbance (e.g, acute psychiatric symptoms which require individual treatment) and/or cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude completion of the assessment measures, interview or informed consent
• Participants or family members who are participating in MSK IHCD studies related to social determinants of health

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase II, Arm 1: Usual and Customary Care (U&C); Participants in this group will receive the same referrals on social and economic resources as ICCAN group.	Behavioral: Usual and Customary Group (U&C); Patients will receive written materials on social and economic resources and services. Treatment Outcomes Survey at Intake, 3 mo, 6 mo, and 1 year. Chart review at 3 mo, 6 mo and 1 year, and as needed.
Phase II, Arm 2: ICCAN-IO; Arm 2 will consist of everything in Arm 1	Behavioral: The Integrated Cancer Care Access Network (ICCAN); Patients will receive written materials on social and economic resources and services. Treatment Outcomes Survey at Intake, 3 mo, 6 mo, and 1 year. Chart review at 3 mo, 6 mo and 1 year, and as needed. Plus Initial needs assessment. Assistance with high priority social and economic needs.Monthly follow-up with ICCAN Access Facilitator to address ongoing needs in addition to as-needed assistance.
Phase I: Refinement; 10 Black, Hispanic, and/or low-SES patients with TNBC (5 Spanish-speaking), will be recruited from MSK	Behavioral: The Integrated Cancer Care Access Network (ICCAN); Patients will receive written materials on social and economic resources and services. Treatment Outcomes Survey at Intake, 3 mo, 6 mo, and 1 year. Chart review at 3 mo, 6 mo and 1 year, and as needed. Plus Initial needs assessment. Assistance with high priority social and economic needs.Monthly follow-up with ICCAN Access Facilitator to address ongoing needs in addition to as-needed assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment completion/adherence	The primary outcome, cancer treatment completion, will be determined by chart review at 3, 6, and 12 months after enrollment.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	depression, and stress (measured through validated scales included in the Cancer Treatment Outcomes	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); The City College of New York; Ralph Lauren Center for Cancer Care and Prevention; Lincoln Medical and Mental Health Center; Lutheran Medical Center
• Investigators: Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Gany F, Melnic I, Li Y, Finik J, Wu M, Ramirez J, Hwang C, Leng J, Blinder V. A Randomized Controlled Trial of the Integrated Cancer Care Access Network on Cancer Treatment Completion and Quality of Life. J Natl Compr Canc Netw. 2025 Jun 10;23(7):e257017. doi: 10.6004/jnccn.2025.7017.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimated): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer; Quality of life; 12-223
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 12-223