Clinical trial NCT01346280: Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs
Official title: Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer (Stage III)
Colon Cancer (Stage II &Amp; III)
Rectal Cancer (Stage III)
Keywords: Adherence to Evidence-Based Guidelines
Multidisciplinary Care
Patient Experiences
Quality of Care Outcomes
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-05-02
Enrollment: 1079
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: 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.

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:

1. Institutional Review Board approval for the multidisciplinary care study at all 16

   sites;
2. The development of a Standard Operating Procedures manual for use by the 16 sites;
3. 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;
4. The development of a data collection form to be used for documenting the facility s

   annual scores using the Multidisciplinary Care Assessment tool.
5. 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;
6. The development of a Frequently Asked Questions document to assist with

   addressing questions in real time;
7. Multiple training sessions/webinars have been held for the participating sites.
8. Monthly conference call with the research team and representatives from all

participating sites.

Eligibility criteria: * 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Kathleen Castro, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.