Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool

Conditions
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Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

Intervention / Treatment
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* Other: Best Practice
* Other: Informational Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC) PART I: English fluency PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC PART II: English fluency PART II: > 6-month life expectancy PART II: Score of > 3 on the 6-Item Screener for Cognitive Impairment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (conversation tool)<br>Patients receive the conversation tool. | Other: Informational Intervention<br>* Receive conversation tool<br>Other: Questionnaire Administration<br>* Ancillary studies - Baseline and follow-up questionnaires<br>|
| Active Comparator: Arm II (usual care)<br>Patients receive usual care. | Other: Best Practice<br>* Receive usual/standard of care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies - Baseline and follow-up questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |