NCT03982459

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

May 27, 2019

Results QC Date

July 29, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Median Change in Decisional Conflict Scale (DCS) Score Over Time

    1 Day

  • Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire

    1 Day

  • Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ)

    1 Day

  • Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire

    1 Day

  • Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)

    1 Day

  • +1 more secondary outcomes

Study Arms (1)

Decision support tool

EXPERIMENTAL

Participants receive training in use of a decision support tool by a trained coordinator.

Behavioral: Decision support tool

Interventions

Internet-Based, interactive decision support tool

Decision support tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 32997124BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Sue Yom, MD
Organization
University of California, San Francisco

Study Officials

  • Sue Yom, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 11, 2019

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

De-identified data will be shared upon request.

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

Locations