Non-Small Cell Lung Cancer (Stage III)NCT01346280
Evaluation of Cancer Care Coordination in the National Cancer Institutes Community Cancer Center Programs
An observational study of Non-Small Cell Lung Cancer (Stage III) and Colon Cancer (Stage II &Amp; III), run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Small Cell Lung Cancer (Stage III), Colon Cancer (Stage II &Amp; III), Rectal Cancer (Stage III)
- How many people
- 1,079 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2011to 5 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Rectal Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study start16 Apr 2011
- Study completion5 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (Stage III)Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 1,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen Castro, R.N., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346280
- Sponsor's protocol ID
- 999911145
- Other IDs
- 11-C-N145
- Status last verified
- 5 Oct 2015
- First submitted
- 29 Apr 2011
- Last updated
- 17 Dec 2019
- Results posted
- No
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.
PubMed 20206544Fennell 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.
PubMed 20386055Sidhom 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.
PubMed 17081921
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Care: The Impact of Multidisciplinary Care on Processes and Outcomes of Cancer Care
- ClinicalTrials.gov ID
- NCT01346280
- Acronym / sponsor ID
- 999911145
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Apr 2011
- Study completion
- 5 Oct 2015
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 20206544Freeman 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.
- Background: PubMed 20386055Fennell 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.
- Background: PubMed 17081921Sidhom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Castro, R.N. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer (Stage III) and Colon Cancer (Stage II &Amp; III), run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.