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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05887 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00020688 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| ATS Foundation | UNKNOWN |
| Hildegard Lamfrom Endowment | UNKNOWN |
| Medical Research Foundation, Oregon |
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This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.
II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the conversation tool.
ARM II: Patients receive usual care.
Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (conversation tool) | Experimental | Patients receive the conversation tool. |
|
| Arm II (usual care) | Active Comparator | Patients receive usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual/standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the conversation tool | The number of patients enrolled divided by the number of patients offered enrollment. | At enrollment |
| Acceptability of the conversation tool | The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool. | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Assessed using the Hospital Anxiety and Depression Scale. | From enrollment to the end of follow-up at 8 weeks |
| Decisional conflict | Assessed using the Decisional Conflict Scale. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Sullivan | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States | ||
| Portland VA Medical Center |
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| OTHER |
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| Informational Intervention | Other | Receive conversation tool |
|
| Questionnaire Administration | Other | Ancillary studies - Baseline and follow-up questionnaires |
|
| At the end of follow-up at 8 weeks |
| Decisional Regret | Assessed using the Decisional Regret Scale. | At the end of follow-up at 8 weeks |
| Perceived involvement in care | Assessed using the Perceived Involvement in Care Scale. | At the end of follow-up at 8 weeks |
| Shared decision-making quality | Assessed using the Shared Decision Making Questionnaire. | At the end of follow-up at 8 weeks |
| Decision making involvement | Assessed using the Control Preferences Scale. | From enrollment to the end of follow-up at 8 weeks |
| Self-efficacy | Assessed using the Decision Self-Efficacy Scale. | From enrollment to the end of follow-up at 8 weeks |
| Values-treatment concordance | Assessed using electronic medical record (EMR). | From enrollment to the end of follow-up at 8 weeks |
| Portland |
| Oregon |
| 97239 |
| United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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