Back to resultsNational Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
decision support tool
Sponsored by
About this trial
This is an interventional supportive care trial for Non-small Cell Lung Cancer
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decision support tool
Arm Description
Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.
Outcomes
Primary Outcome Measures
Quality of Care
Change in percentage of patients receiving care according to 6 selected NCCN recommendations
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03982459
First Posted
May 27, 2019
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
Collaborators
National Comprehensive Cancer Network
1. Study Identification
Unique Protocol Identification Number
NCT03982459
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Comprehensive Cancer Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision support tool
Arm Type
Experimental
Arm Description
Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.
Intervention Type
Behavioral
Intervention Name(s)
decision support tool
Intervention Description
computerized online decision support tool
Primary Outcome Measure Information:
Title
Quality of Care
Description
Change in percentage of patients receiving care according to 6 selected NCCN recommendations
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Change in Decisional Conflict
Description
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.
Time Frame
1 Day
Title
Satisfaction with Health Care Decision
Description
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.
Time Frame
1 Day
Title
Characterize Decisional Support Preference
Description
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.
Time Frame
1 Day
Title
Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire
Description
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.
Time Frame
1 Day
Title
Lung Cancer Symptom Evaluation Score by the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17)
Description
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.
Time Frame
1 Day
Title
Post Consultation Agreement Between Patient and Physician
Description
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.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Yom, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared on request.
IPD Sharing Time Frame
available now
IPD Sharing Access Criteria
request to Principal Investigator
Citations:
PubMed Identifier
32997124
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.
Results Reference
derived
Learn more about this trial
National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC
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