Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Cancer Patients

Treatments: Behavioral: Usual and Customary Group (U&C); Behavioral: The Integrated Cancer Care Access Network (ICCAN)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01742143

12-223

Details and patient eligibility

About

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).

Enrollment: 347 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

347 participants in 3 patient groups

Phase I: Refinement

Description:

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

Treatment:

Behavioral: The Integrated Cancer Care Access Network (ICCAN)

Phase II, Arm 1: Usual and Customary Care (U&C)

Description:

Participants in this group will receive the same referrals on social and economic resources as ICCAN group.

Treatment:

Behavioral: Usual and Customary Group (U&C)

Phase II, Arm 2: ICCAN-IO

Description:

Arm 2 will consist of everything in Arm 1

Treatment:

Behavioral: The Integrated Cancer Care Access Network (ICCAN)