Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Cancer Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742143
• Other study ID #: 12-223
• Status: Recruiting
• Start date: November 2012
• Est. completion date: November 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Francesca Gany, MD, MS
• Phone: 646-888-8054
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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
• 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 in Harlem, Nassau, or Manhattan
• 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:

• diagnosed with Stage IV disease
• 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
• has another family member already enrolled in ICCAN (as determined by patient report)

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

• Started immunotherapy
• Presence of untreated psychiatric disturbance (i.e. 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
• Has another family member already enrolled in ICCAN
• Already participating in or already completed the ICCAN program

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

• Started immunotherapy
• Presence of untreated psychiatric disturbance (i.e. 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
• Has another family member already enrolled in ICCAN
• Already participating in or already completed the ICCAN program.

Related Conditions & MeSH terms

• Cancer Patients

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lincoln Hospital and Mental Health Center	Bronx	New York
United States	Lutheran Medical Center	Brooklyn	New York
United States	City College of New York (Data Collection AND Data Analysis)	New York	New York
United States	Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Lincoln Medical and Mental Health Center, Lutheran Medical Center, National Cancer Institute (NCI), Ralph Lauren Center for Cancer Care and Prevention, The City College of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life	depression, and stress (measured through validated scales included in the Cancer Treatment Outcomes	1 year

External Links

•   Memorial Sloan Kettering Cancer Center