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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision support tool | Experimental | Participants receive training in use of a decision support tool by a trained coordinator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision support tool | Behavioral | Internet-Based, interactive decision support tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | 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. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in Decisional Conflict Scale (DCS) Score Over Time | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Yom, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32997124 | Background | 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. |
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De-identified data will be shared upon request.
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Requests for datasets should be sent to the Principal Investigator for review and approval for dissemination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Support Tool | Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Support Tool | Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Reporting Quality of Care on Selected National Comprehensive Cancer Center (NCCN) Recommendations | 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. | Nine participants were missing survey results preventing calculation for this measure | Posted | Number | percentage of participants | 1 Day |
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Support Tool | Participants receive training in use of a decision support tool by a trained coordinator at a single clinic visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sue Yom, MD | University of California, San Francisco | 415-353-7175 | sue.yom@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2016 | Nov 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 30, 2015 | Nov 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 1 Day |
| Median Scores by Item on the Satisfaction With Health Care Decision 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. | 1 Day |
| Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | 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. | 1 Day |
| Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) 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. | 1 Day |
| Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17) | 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. | 1 Day |
| Percentage of Participants With Reported Agreement at Post Consultation With Physician | 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. | 1 Day |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Decision Support Tool | 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 |
|
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| Secondary | Median Change in Decisional Conflict Scale (DCS) Score Over Time | 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. | Nine participants did not complete the questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | 1 Day |
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|
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| Secondary | Median Scores by Item on the Satisfaction With Health Care Decision 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. | Six participants did not complete the questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | 1 Day |
|
|
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| Secondary | Number of Participants by Response on the Decisional Support Preference Questionnaire (DMPQ) | 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. | Five participants did not complete the questionnaire | Posted | Count of Participants | Participants | 1 Day |
|
|
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| Secondary | Median Total Score on the Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) 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. | Two participants did not complete the questionnaire. | Posted | Mean | Full Range | score on a scale | 1 Day |
|
|
|
| Secondary | Median Scores on the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17) | 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. | data not collected | Posted | 1 Day |
|
|
| Secondary | Percentage of Participants With Reported Agreement at Post Consultation With Physician | 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. | Only 45 participants completed the questionnaire | Posted | Number | percentage of participants | 1 Day |
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| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| I expect to successfully carry out (or continue to carry out) the decision I made |
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| I am satisfied that this was my decision to make |
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| I am satisfied with my decision |
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| I should make decisions but strongly consider the doctor's opinion |
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| I should make the decision |
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