Impact of ICCAN on Cancer Treatment Completion and Quality of Life
This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
The City College of New York
Ralph Lauren Center for Cancer Care and Prevention
Lincoln Hospital
Lutheran Medical Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01742143
First received: December 3, 2012
Last updated: April 24, 2013
Last verified: April 2013
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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 |
|---|---|
|
Newly Diagnosed Breast Cancer Newly Diagnosed Colon Cancer Newly Diagnosed Lung Cancer |
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 2014 |
| Estimated Primary Completion Date: | November 2014 (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
Newly diagnosed (at the onset of treatment) breast, colon and lung 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). During cancer clinic hours.
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.
- has a new diagnosis of either breast, colon or lung cancer (diagnosed within the past month) 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
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 | Not yet 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: Aparna Sarin, 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 Hospital
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: | April 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Quality of life lung breast colon 12-223 |
Additional relevant MeSH terms:
|
Breast Neoplasms Colonic Neoplasms Lung Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013