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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982459
• Other study ID #: 14655
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: September 1, 2018

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Behavioral:
• decision support tool
computerized online decision support tool

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Care	Change in percentage of patients receiving care according to 6 selected NCCN recommendations	1 Day
Secondary	Change in Decisional Conflict	Change in level of decisional conflict will be assessed by the Decisional Conflict Scale (DCS). Assessment will be completed before and after consultation. The DCS is a scale designed to measure patients' uncertainty in making health-related decisions, factors contributing to uncertainty, and patients' perceived effective decision-support. The DCS has 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.	1 Day
Secondary	Satisfaction with Health Care Decision	Satisfaction will be assessed using the Patient Satisfaction with Health Care Decision (SWD) six-item scale. The SWD will be completed once after the consultation. The range of scoring on this instrument is 0-30, with 30 indicating the highest satisfaction with decision.	1 Day
Secondary	Characterize Decisional Support Preference	Patients' preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ will be completed once before the consultation. 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 the intermediate state of shared decision making. There are choices from 1-5 with 5 indicating the most active decision making preference.	1 Day
Secondary	Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire	Quality of life will be assessed using the FACT-L quality of life instrument, a 44-item self-report questionnaire that uses a five-point Likert scale. The FACT-L will be completed once before the consultation. The FACT-L is graded on a scale from 0-84 with a lung cancer subscale that ranges from 0-24 with the higher scores indicating better quality of life.	1 Day
Secondary	Lung Cancer Symptom Evaluation Score by the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)	Patients' symptoms will be evaluated using the National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17), a 17-item patient-reported questionnaire that uses a five-point Likert scale and is scored from 0-68. It includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being. The NFLSI-17 will be completed once before the consultation.	1 Day
Secondary	Post Consultation Agreement Between Patient and Physician	By using a post-consultation questionnaire, we will determine the level of agreement between patient and physician with respect to treatments discussed and recommended, prognosis, and expected tolerance.	1 Day