Clinical trial NCT03982459: National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC
Official title: Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2019-06-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations
timeFrame: 1 Day
Secondary outcomes:
measure: Median Change in Decisional Conflict Scale (DCS) Score Over Time
timeFrame: 1 Day
measure: Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire
timeFrame: 1 Day
measure: Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ)
timeFrame: 1 Day
measure: Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire
timeFrame: 1 Day
measure: Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)
timeFrame: 1 Day
measure: Percentage of Participants With Reported Agreement at Post Consultation With Physician
timeFrame: 1 Day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sue Yom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.