- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346280
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs
Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care
Background:
-Coordinated cancer care provided by doctors, nurses, social workers, and other care providers is believed to improve patient and physician satisfaction and patient evaluation for enrollment in clinical trials. But no research has been done to show that this approach improves patient experiences and outcomes. Researchers want to study this model to better understand how it can improve cancer treatment and patient outcomes.
Objectives:
- To assess the relationship between coordinated care and cancer treatment processes and outcomes.
Eligibility:
- Individuals who are at least 18 years of age. Those who take part must have been diagnosed with colon, rectal, or non-small-cell lung cancer. They also must be receiving or have been treated at one of the 16 NCI Community Cancer Center program sites.
Design:
- Researchers will collect medical records data from participants.
- Participants will complete a questionnaire about 8 weeks after the end of all planned cancer treatment. They will be asked questions about their experience with coordinated cancer care. They will also be asked for any comments or concerns they had during and after treatment.
- No treatment or additional tests will be provided as part of this protocol.
Study Overview
Status
Detailed Description
There is little evidence regarding the effect of multidisciplinary care (MDC) on health outcomes across various cancer sites, including colon, rectal, and lung cancer. The current study addresses this gap by providing preliminary data regarding the relationship between MDC and selected processes and outcomes of care in NCCCP pilot sites. The long-term goal of this preliminary study is to generate effect sizes, establish feasibility, and build infrastructure to support the development of a larger more definitive study of MDC outcomes. The key aim of this pilot study is to determine the relationship between specific MDC assessment areas identified by a pre-existing MDC assessment tool (http://ncccp .cancer.gov /NCCCPMDC- Matrix- Tool. pdf ): case planning, physician engagement, coordination of care, infrastructure, financial, clinical trials and medical records, and each of the following outcomes [0] and processes [P]: 1) time to receipt of initial therapy[P]; 2) receipt of multi-modality therapy[O]; 3) evaluation for enrollment in a clinical trial[P]; 4) patient experience[O]; 5) adherence to NCCN treatment guidelines[P]; and 6) all-cause survival[O]. The study focuses on adult patients with an incident diagnosis of Stage III colon cancer, Stage II or III rectal cancer, or Stage III non-small cell lung cancer.
We will quantify the relationship between MDC, various care processes and outcomes across 16 participating NCCCP sites, testing the hypothesis that increasing levels of MDC identified by the MDC tool are associated with improvement in care quality and a survival advantage.
Significant progress has been achieved in the past year establishing the necessary
processes for conducting the research study and the deliverables associated with the study. In terms of process outcomes, we can report the following:
Institutional Review Board approval for the multidisciplinary care study at all 16
sites;
- The development of a Standard Operating Procedures manual for use by the 16 sites;
The development of a data collection form (Site Data Collection Tool) to be used for
collecting information that is not available via the pre-existing web-based data
collection system that is in place at the 16 sites;
The development of a data collection form to be used for documenting the facility s
annual scores using the Multidisciplinary Care Assessment tool.
The development of a flowchart for use in operationalizing the measurement of
NCCN guideline adherence for patients with Stage III non small cell lung cancer;
The development of a Frequently Asked Questions document to assist with
addressing questions in real time;
- Multiple training sessions/webinars have been held for the participating sites.
- Monthly conference call with the research team and representatives from all
participating sites.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI), 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Stage III colon cancer, Stage II or III rectal cancer or Stage III lung cancer. Additional inclusion criteria: Age: equal to or greater than 18 at time of diagnosis; English speaking (native or non-native); First or only cancer diagnosis; All or part of first course of treatment was performed at the reporting facility.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Freeman RK, Van Woerkom JM, Vyverberg A, Ascioti AJ. The effect of a multidisciplinary thoracic malignancy conference on the treatment of patients with lung cancer. Eur J Cardiothorac Surg. 2010 Jul;38(1):1-5. doi: 10.1016/j.ejcts.2010.01.051. Epub 2010 Mar 4.
- Fennell ML, Das IP, Clauser S, Petrelli N, Salner A. The organization of multidisciplinary care teams: modeling internal and external influences on cancer care quality. J Natl Cancer Inst Monogr. 2010;2010(40):72-80. doi: 10.1093/jncimonographs/lgq010.
- Sidhom MA, Poulsen MG. Multidisciplinary care in oncology: medicolegal implications of group decisions. Lancet Oncol. 2006 Nov;7(11):951-4. doi: 10.1016/S1470-2045(06)70942-1.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Colorectal Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Rectal Neoplasms
- Colonic Neoplasms
Other Study ID Numbers
- 999911145
- 11-C-N145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small Cell Lung Cancer (Stage III)
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Oslo University HospitalAstraZenecaActive, not recruitingCancer | NSCLC | Non Small Cell Lung Cancer | NSCLC, Stage III | Non Small Cell Lung Cancer Stage IIINorway, Finland, Lithuania, Estonia
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Northwestern UniversityBristol-Myers Squibb; National Cancer Institute (NCI)UnknownStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage III Non-Small Cell Lung CancerUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
National Cancer Institute (NCI)NRG OncologyTerminatedStage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7United States
-
Assistance Publique - Hôpitaux de ParisBristol-Myers SquibbTerminatedNon Small Cell Lung Cancer | Non-small Cell Lung Cancer Stage IV | Non Small Cell Lung Cancer Stage III | Non-Small Cell Carcinoma of LungFrance
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedStage IV Non-Small Cell Lung Cancer AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7 | Mesothelin PositiveUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Non-Small Cell Lung Cancer AJCC v7 | Stage IIIA Non-Small Cell Lung Cancer AJCC v7 | Stage III Non-Small Cell Lung Cancer AJCC v7 | Stage IIIB Non-Small Cell Lung Cancer AJCC v7United States