Trial Outcomes & Findings for National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC (NCT NCT03982459)

Last Updated: 2025-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

1 Day

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Decision Support Tool Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit.
Overall Study STARTED	76
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Support Tool n=76 Participants Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: Nine participants were missing survey results preventing calculation for this measure

Outcome measures

Outcome measures
Measure	Decision Support Tool n=65 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Documented smoking cessation counseling or intervention in active smokers	80 percentage of participants
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Adjuvant chemotherapy for participants with stage IB-IIB disease following surgery	0 percentage of participants
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Pathologic mediastinal staging completed before surgery for patients with stage III disease	50 percentage of participants
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Pathologic mediastinal staging before treatment initiation for stage III not undergoing surgery	28.6 percentage of participants
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Initial chemoradiotherapy for participants with stage III disease not undergoing surgery	64.3 percentage of participants
Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations Testing for EGFR or ALK gene alteration status for participants with stage IV disease	91.3 percentage of participants

SECONDARY outcome

Timeframe: 1 Day

Population: Nine participants did not complete the questionnaire

Change in level of decisional conflict will be assessed by the DCS completed before and after consultation. The DCS is a scale designed to measure participants' uncertainty in making health-related decisions, factors contributing to uncertainty, and participants perceived effective decision-support. The DCS has a total of 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. The median change in score over time and the interquartile range will be reported.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=65 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Median Change in Decisional Conflict Scale (DCS) Score Over Time	20 score on a scale Interval 3.0 to 34.0

SECONDARY outcome

Timeframe: 1 Day

Population: Six participants did not complete the questionnaire

The Patient Satisfaction with Health Care Decision (SWD) Questionnaire is a six-item survey with item responses ranging from 1 -5 with a higher value indicating a higher degree of satisfaction or agreement with the statement. The median score of each item and the interquartile range will be reported.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=70 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire I am satisfied that I am adequately informed about the issues important to my decision	4 score on a scale Interval 4.0 to 5.0
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire The decision I made was the best decision possible for me personally	4 score on a scale Interval 3.0 to 5.0
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire I am satisfied that my decision was consistent with my personal values	4 score on a scale Interval 3.0 to 5.0
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire I expect to successfully carry out (or continue to carry out) the decision I made	4 score on a scale Interval 4.0 to 5.0
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire I am satisfied that this was my decision to make	4 score on a scale Interval 4.0 to 5.0
Median Scores by Item on the Satisfaction With Health Care Decision Questionnaire I am satisfied with my decision	4 score on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 1 Day

Population: Five participants did not complete the questionnaire

Participants preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). 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 a combination of shared decision making ranging from the most passive in self-decision making preference to the most active in self-decision making. The number of participants by response will be reported.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=71 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) Doctor should make the decisions	5 Participants
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) Doctor should make the decisions but strongly consider my opinion	12 Participants
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) Doctor and I should make the decisions together	39 Participants
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) I should make decisions but strongly consider the doctor's opinion	13 Participants
Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) I should make the decision	2 Participants

SECONDARY outcome

Timeframe: 1 Day

Population: Two participants did not complete the questionnaire.

The Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-report instrument that measures multidimensional quality of life for patients with lung cancer. Each item is rated on a 5-point Likert scale ranging from 0 = "Not at all" to 4 = "Very much" with a total score range of 0-144, and higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=74 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire	67 score on a scale Interval 61.0 to 75.0

SECONDARY outcome

Timeframe: 1 Day

Population: data not collected

The NCCN/FACT Lung Cancer Symptom Index-17 (NFLSI-17) is a brief symptom index for patients with advanced lung cancer. The NFLSI-17 is a 17-item patient-reported questionnaire. Each item is rated on a 5-point Likert scale ranging from 0 = "Not at all" to 4 = "Very much" with a total score range of 0-68. The questionnaire includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being with higher scores indicating lower overall symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Day

Population: Only 45 participants completed the questionnaire

The percentage of participants who completed the post-consultation questionnaire and reported achieving agreement on treatment recommendations between the participants and the physician with respect to treatments discussed and recommended, prognosis, and expected tolerance will be reported.

Outcome measures

Outcome measures
Measure	Decision Support Tool n=45 Participants Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator. decision support tool: computerized online decision support tool
Percentage of Participants With Reported Agreement at Post Consultation With Physician	93.3 percentage of participants

Adverse Events

Decision Support Tool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sue Yom, MD

University of California, San Francisco

Phone: 415-353-7175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place