National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC

January 6, 2025 updated by: University of California, San Francisco

Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines

This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population. The decision support tool is offered by a trained coordinator to the patient and then utilized during an initial consultation. Patients complete forms before and after the visit indicating their level of decisional conflict, satisfaction, and satisfaction with decision. Pre-determined indices of quality of care were also collected by the study team.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over age of 18
  • Able to provide informed consent
  • Able to use a web-based interface
  • Histologically proven or clinically apparent diagnosis of non-small cell lung cancer
  • Newly diagnosed, with new primary occurrence of NSCLC, or diagnosed with a new recurrence or new progression of existing disease, and not yet treated for the new problem
  • Being seen in consultation at thoracic oncology clinics

Exclusion Criteria:

  • Unable to fill out questionnaires
  • Already treated for the current diagnosis of a new primary occurrence of NSCLC, or already treated for the new recurrence or new progression of existing disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Decision support tool
Participants receive training in use of a decision support tool by a trained coordinator.
Behavioral: Decision support tool
Internet-Based, interactive decision support tool

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations
Time Frame: 1 Day
Participants explored individually tailored decision trees derived from the NCCN guidelines. Six benchmarks of quality care derived from the guidelines were evaluated: (1) documented smoking cessation counseling in active smokers, (2) adjuvant chemotherapy for patients with stage IB to IIB NSCLC after surgery, (3) pathologic mediastinal staging in patients with stage III NSCLC before surgery, (4) pathologic mediastinal staging in patients with stage III NSCLC before nonsurgical management, (5) definitive chemoradiotherapy for patients with stage III NSCLC not undergoing surgery, and (6) molecular testing for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) alterations for patients with stage IV NSCLC. Because the decision trees were tailored, not all participants evaluated all 6 benchmarks. The percentage of participants who interacted with each benchmark and demonstrated quality of care will be reported.
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Change in Decisional Conflict Scale (DCS) Score Over Time
Time Frame: 1 Day
Change in level of decisional conflict will be assessed by the DCS completed before and after consultation. The DCS is a scale designed to measure participants' uncertainty in making health-related decisions, factors contributing to uncertainty, and participants perceived effective decision-support. The DCS has a total of 16 items and uses a five-point Likert scale for each item. The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict. The median change in score over time and the interquartile range will be reported.
1 Day
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire
Time Frame: 1 Day

The Patient Satisfaction with Health Care Decision (SWD) Questionnaire is a six-item survey with item responses ranging from 1 -5 with a higher value indicating a higher degree of satisfaction or agreement with the statement.

The median score of each item and the interquartile range will be reported.
1 Day
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ)
Time Frame: 1 Day
Participants preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or a combination of shared decision making ranging from the most passive in self-decision making preference to the most active in self-decision making. The number of participants by response will be reported.
1 Day
Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire
Time Frame: 1 Day
The Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-report instrument that measures multidimensional quality of life for patients with lung cancer. Each item is rated on a 5-point Likert scale ranging from 0 = "Not at all" to 4 = "Very much" with a total score range of 0-144, and higher scores indicating a better quality of life.
1 Day
Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)
Time Frame: 1 Day
The NCCN/FACT Lung Cancer Symptom Index-17 (NFLSI-17) is a brief symptom index for patients with advanced lung cancer. The NFLSI-17 is a 17-item patient-reported questionnaire. Each item is rated on a 5-point Likert scale ranging from 0 = "Not at all" to 4 = "Very much" with a total score range of 0-68. The questionnaire includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being with higher scores indicating lower overall symptoms.
1 Day
Percentage of Participants With Reported Agreement at Post Consultation With Physician
Time Frame: 1 Day
The percentage of participants who completed the post-consultation questionnaire and reported achieving agreement on treatment recommendations between the participants and the physician with respect to treatments discussed and recommended, prognosis, and expected tolerance will be reported.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Comprehensive Cancer Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sue Yom, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared upon request.

IPD Sharing Time Frame

available now

IPD Sharing Access Criteria

Requests for datasets should be sent to the Principal Investigator for review and approval for dissemination.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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