National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC
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|ClinicalTrials.gov Identifier: NCT03982459|
Recruitment Status : Completed
First Posted : June 11, 2019
Last Update Posted : March 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Behavioral: decision support tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines|
|Actual Study Start Date :||February 1, 2015|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||September 1, 2018|
Experimental: Decision support tool
Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.
Behavioral: decision support tool
computerized online decision support tool
- Quality of Care [ Time Frame: 1 Day ]Change in percentage of patients receiving care according to 6 selected NCCN recommendations
- Change in Decisional Conflict [ Time Frame: 1 Day ]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 [ Time Frame: 1 Day ]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 [ Time Frame: 1 Day ]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 [ Time Frame: 1 Day ]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) [ Time Frame: 1 Day ]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 [ Time Frame: 1 Day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982459
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Sue Yom, MD, PhD||University of California, San Francisco|