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Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Recruiting
Conditions
Cancer Patients
Interventions
Behavioral: The Integrated Cancer Care Access Network (ICCAN)
Behavioral: Usual and Customary Group (U&C)
Registration Number
NCT01742143
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Brief 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
334
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

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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
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Phase I: RefinementThe Integrated Cancer Care Access Network (ICCAN)10 Black, Hispanic, and/or low-SES patients with TNBC (5 Spanish-speaking), will be recruited from MSK
Phase II, Arm 1: Usual and Customary Care (U&C)Usual and Customary Group (U&C)Participants in this group will receive the same referrals on social and economic resources as ICCAN group.
Phase II, Arm 2: ICCAN-IOThe Integrated Cancer Care Access Network (ICCAN)Arm 2 will consist of everything in Arm 1
Primary Outcome Measures
NameTimeMethod
Treatment completion/adherence1 year

The primary outcome, cancer treatment completion, will be determined by chart review at 3, 6, and 12 months after enrollment.

Secondary Outcome Measures
NameTimeMethod
Quality of life1 year

depression, and stress (measured through validated scales included in the Cancer Treatment Outcomes

Trial Locations

Locations (11)

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

🇺🇸

Montvale, New Jersey, United States

Lincoln Hospital and Mental Health Center

🇺🇸

Bronx, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

🇺🇸

Rockville Centre, New York, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

🇺🇸

Commack, New York, United States

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

🇺🇸

New York, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

🇺🇸

Basking Ridge, New Jersey, United States

Lutheran Medical Center

🇺🇸

Brooklyn, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

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 Monmouth (Limited Protocol Activities)

🇺🇸

Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

🇺🇸

Harrison, New York, United States

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