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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346280
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


-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.


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

  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 /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


  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.

Study Type : Observational
Actual Enrollment : 1079 participants
Time Perspective: Other
Official Title: Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care
Study Start Date : April 16, 2011
Study Completion Date : October 5, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346280

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

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01346280     History of Changes
Other Study ID Numbers: 999911145
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: October 5, 2015

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases