Clinical trial NCT01742143: Impact of ICCAN on Cancer Treatment Completion and Quality of Life
Official title: A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Patients
Keywords: Quality of life
cancer
12-223
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The City College of New York
name: Ralph Lauren Center for Cancer Care and Prevention
name: Lincoln Medical and Mental Health Center
name: Lutheran Medical Center
First posted: 2012-12-05
Enrollment: 347
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible cancer patients will be recruited in person by multilingual ICCAN Clinical Research Coordinators for participation in the study at Ralph Lauren Center for Cancer Care and Prevention (RLCCP), Lincoln Hospital (LH) and Lutheran Medical Center (LMC). In the event that MSK staff is not present when an eligible patient is identified. Refinement and Pilot RCT participants will be recruited through MSK Manhattan and OneMSK regional sites's.

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).


Eligibility 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

Primary outcomes:
measure: Treatment completion/adherence
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Bronx
country: United States
facility: Lincoln Hospital and Mental Health Center
state: New York
city: Brooklyn
country: United States
facility: Lutheran Medical Center
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: City College of New York (Data Collection AND Data Analysis)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: