Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01346280
First received: April 29, 2011
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

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.

Condition
Non-Small Cell Lung Cancer (Stage III)
Colon Cancer (Stage II & Amp; III)
Rectal Cancer (Stage III)

Study Type: Observational
Official Title: Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1695
Study Start Date: April 2011
  Hide Detailed Description

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT01346280

Locations
United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Kathleen Castro, R.N. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01346280     History of Changes
Other Study ID Numbers: 999911145, 11-C-N145
Study First Received: April 29, 2011
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Adherence to Evidence-Based Guidelines
Multidisciplinary Care
Patient Experiences
Quality of Care Outcomes

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014