RecruitingNCT01742143

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

347 participants

Start Date

Nov 1, 2012

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria27

  • 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 Criteria8

  • 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

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Interventions

BEHAVIORALThe 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.

BEHAVIORALUsual 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(11)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Lutheran Medical Center

Brooklyn, New York, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, 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, United States

Lincoln Hospital and Mental Health Center

The Bronx, New York, United States

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NCT01742143


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