Impact of ICCAN on Cancer Treatment Completion and Quality of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
The City College of New York
Ralph Lauren Center for Cancer Care and Prevention
Lincoln Medical and Mental Health Center
Lutheran Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01742143
First received: December 3, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention
Cancer Patients
Behavioral: The Integrated Cancer Care Access Network (ICCAN)
Behavioral: Usual and Customary Group (U&C)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Treatment completion/adherence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome, cancer treatment completion, will be determined by chart review at 3, 6, and 12 months after enrollment.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    depression, and stress (measured through validated scales included in the Cancer Treatment Outcomes


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICCAN
For those randomized into the ICCAN arm, the core of the intervention will be three ICCAN Access Facilitators who will assess needs and synchronize for each patient an individualized set of transdisciplinary services.
Behavioral: 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.

Usual and Customary Group (U&C)
Participants in this group will receive the same written materials on social and economic resources as ICCAN group.
Behavioral: 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.


  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Eligible cancer patients will be recruited in person by multilingual ICCAN research assistants 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 MSKCC staff is not present when an eligible patient is identified on site, potential patients may be referred to MSKCC for screening and enrollment using a Referral/Permission to Contact Form.

Criteria

Inclusion Criteria:

  • fluent in English, Spanish, or Mandarin
  • between the ages of 21-80 years old
  • In the Investigator's judgment, participants must have satisfactory cognitive function to provide valid informed consent and participate in the ICCAN intervention. The Blessed Orientation-Memory Concentration test (BOMC) will be used as a cognitive screening tool. Patients must have a BOMC score of less than or equal to 11.
  • 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

Exclusion Criteria:

  • diagnosed with Stage IV disease
  • presence of cognitive impairment disorder (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection. (BOMC >11).
  • has another family member already enrolled in ICCAN (as determined by patient report)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742143

Contacts
Contact: Francesca Gany, MD, MS 646-888-4240
Contact: Jennifer Leng, MD, MPH 646-888-4243

Locations
United States, New York
Lincoln Hospital and Mental Health Center Recruiting
Bronx, New York, United States
Contact: Niyati Bhagwati, MD    718-579-5000      
Lutheran Medical Center Not yet recruiting
Brooklyn, New York, United States
Contact: Audrey Saitta, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Francesca Gany, MD, MS    646-888-4240      
Contact: Jennifer Leng, MD, MPH    646-888-4243      
Principal Investigator: Francesca Gany, MD, MS         
Ralph Lauren Center for Cancer Care and Prevention Not yet recruiting
New York, New York, United States, 10035
Contact: Gina P. Villani, MD         
Contact: Joseph Yoe, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
The City College of New York
Ralph Lauren Center for Cancer Care and Prevention
Lincoln Medical and Mental Health Center
Lutheran Medical Center
Investigators
Principal Investigator: Francesca Gany, MD, MS Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01742143     History of Changes
Other Study ID Numbers: 12-223
Study First Received: December 3, 2012
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of life
cancer
12-223

ClinicalTrials.gov processed this record on August 28, 2014