Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Официальное название

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

Обзор

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).

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Treatment completion/adherence [Срок оценки: 1 year]

Вторичные конечные точки (1)

• Quality of life [Срок оценки: 1 year]

Критерии участия

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

CCAN-GBM

• Over the age of 18 (per EMR)
• Diagnosed with Glioblastoma (per EMR)
• Has not yet started radiation and concurrent temozolomide treatment (per EMR)
• Has a primary neuro-oncologist at MSK (per EMR)
• Will be undergoing radiation at MSK (per EMR)
• Treatment plan consists of a 6-week or 3-week (hypofractionated) course of radiation and chemotherapy (per EMR)
• Participant or caregiver is fluent in English or Spanish
• Planning on remaining in the tri-state area during the 6 weeks or 3 weeks of radiation and chemotherapy (per self-report)
• Screens positive on SDOH screening tool, referred by the clinical team through traditional screening tools for SDOH assistance (per EMR or self-report), demonstrates financial need per MSK guidelines (up to 500% of the federal poverty limit), and/or requests help with SDOH resources or navigation

Participant Exclusion Criteria:

Patient is ineligible if 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:

• 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 at the PI's discretion

ICCAN-GBM

• No recurrences - must be newly diagnosed glioblastoma (per EMR)
• Patients undergoing different treatment regimens from the 15 fraction/3 week or 30 fraction/6 week course of radiation (i.e. patients undergoing 10 fractions of palliative radiation due to poor functional status) (per EMR)
• Presence of untreated psychiatric disturbance (i.e. acute psychiatric symptoms that require individual treatment) (per EMR or self-report)
• Severe cognitive impairment or fluent aphasia as not to understand the assessment measures, interview, or informed consent, without a health care proxy or caregiver that can assist as indicated by clinician or per judgement of study staff. Completion of assessments with the help of caregivers is acceptable. (per EMR or self-report)
• Has another family member or household member already enrolled in ICCAN (per self-report)
• Already participated in or already completed the ICCAN program (per self-report)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 11 центров

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
• Lutheran Medical Center — Brooklyn
• Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
• City College of New York (Data Collection AND Data Analysis) — New York
• Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities) — New York
• … и ещё 3 центра

Публикации

• Gany F, Melnic I, Li Y, Finik J, Wu M, Ramirez J, Hwang C, Leng J, Blinder V. A Randomized Controlled Trial of the Integrated Cancer Care Access Network on Cancer Treatment Completion and Quality of Life. J Natl Compr Canc Netw. 2025 Jun 10;23(7):e257017. doi: 10.6004/jnccn.2025.7017. PMID 40494401

Идентификаторы

NCT: NCT01742143 · 12-223

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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