Impact of ICCAN on Cancer Treatment Completion and Quality of Life

NCT ID: NCT01742143

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2026-11-30

Brief Summary

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The purpose of this 1 year 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).

Detailed Description

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Conditions

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Cancer Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase I: Refinement

10 Black, Hispanic, and/or low-SES patients with TNBC (5 Spanish-speaking), will be recruited from MSK

The Integrated Cancer Care Access Network (ICCAN)

Intervention Type BEHAVIORAL

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 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.

Usual and Customary Group (U&C)

Intervention Type BEHAVIORAL

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

The Integrated Cancer Care Access Network (ICCAN)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The City College of New York

OTHER

Sponsor Role collaborator

Ralph Lauren Center for Cancer Care and Prevention

OTHER

Sponsor Role collaborator

Lincoln Medical and Mental Health Center

OTHER

Sponsor Role collaborator

Lutheran Medical Center

UNKNOWN

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesca Gany, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Lutheran Medical Center

Brooklyn, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

City College of New York (Data Collection AND Data Analysis)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Lincoln Hospital and Mental Health Center

The Bronx, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Francesca Gany, MD, MS

Role: CONTACT

646-888-8054

Jennifer Leng, MD, MPH

Role: CONTACT

646-888-4243

Facility Contacts

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Francesca Gany, MD, MS

Role: primary

646-888-8054

Fransecsa Gany, MD, MS

Role: primary

646-888-8054

Francesca Gany, MD, MS

Role: primary

646-888-8054

Francesca Gany, MD, MS

Role: primary

646-888-8054

Francesca Gany, MD, MS

Role: primary

646-888-8054

Adriana Espinosa, MD

Role: primary

212-650-8404

Francesca Gany, MD

Role: primary

646-888-8054

Francesca Gany, MD, MS

Role: primary

646-888-8054

Jennifer Leng, MD, MPH

Role: backup

646-888-4243

Franscesca Gany, MD, MS

Role: primary

646-888-8054

References

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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.

Reference Type DERIVED
PMID: 40494401 (View on PubMed)

Related Links

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http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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12-223

Identifier Type: -

Identifier Source: org_study_id

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