Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs
|First Received Date ICMJE||April 29, 2011|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||April 16, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01346280 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs|
|Official Title ICMJE||Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care|
-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.
- To assess the relationship between coordinated care and cancer treatment processes and outcomes.
- 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.
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  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:
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||1695|
|Estimated Completion Date||October 5, 2015|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||18 Years to 99 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01346280|
|Other Study ID Numbers ICMJE||999911145
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Cancer Institute (NCI)|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||October 5, 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP