NCT01742143 Impact of ICCAN on Cancer Treatment Completion and Quality of Life
| NCT ID | NCT01742143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Cancer Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 347 participants |
| Start Date | 2012-11 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 347 participants in total. It began in 2012-11 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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)
Contact & Investigator
Francesca Gany, MD, MS
📞 646-888-8054
Francesca Gany, MD, MS
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT01742143 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01742143 currently recruiting?
Yes, NCT01742143 is actively recruiting participants. Visit ClinicalTrials.gov or contact Memorial Sloan Kettering Cancer Center to inquire about joining.
Where is the NCT01742143 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Brooklyn, United States and 7 additional locations.
Who is sponsoring the NCT01742143 clinical trial?
NCT01742143 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Francesca Gany, MD, MS at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 347 participants.
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