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

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: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Behavioral: Decision support tool

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: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations	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

Outcome Measure	Measure Description	Time Frame
Median Change in Decisional Conflict Scale (DCS) Score Over Time	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	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)	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	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)	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	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

• Sponsor: University of California, San Francisco
• Collaborators: National Comprehensive Cancer Network
• Investigators: Principal Investigator: Sue Yom, MD, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• Wu SY, Lazar AA, Gubens MA, Blakely CM, Gottschalk AR, Jablons DM, Jahan TM, Wang VEH, Dunbar TL, Wong ML, Chan JW, Guthrie W, Belkora J, Yom SS. Evaluation of a National Comprehensive Cancer Network Guidelines-Based Decision Support Tool in Patients With Non-Small Cell Lung Cancer: A Nonrandomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e209750. doi: 10.1001/jamanetworkopen.2020.9750.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 9, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID 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