Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Study Overview
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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).

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

Conditions
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Cancer Patients

Intervention / Treatment
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* Behavioral: The Integrated Cancer Care Access Network (ICCAN)
* Behavioral: Usual and Customary Group (U&C)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I: Refinement<br>10 Black, Hispanic, and/or low-SES patients with TNBC (5 Spanish-speaking), will be recruited from MSKC | Behavioral: The Integrated Cancer Care Access Network (ICCAN)<br>* 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.<br>|
| Phase II, Arm 1: Usual and Customary Care (U&C)<br>Participants in this group will receive the same referrals on social and economic resources as ICCAN group. | Behavioral: Usual and Customary Group (U&C)<br>* 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.<br>|
| Phase II, Arm 2: ICCAN-IO<br>Arm 2 will consist of everything in Arm 1 | Behavioral: The Integrated Cancer Care Access Network (ICCAN)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, cancer, 12-223