Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool

Study Overview
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Brief Summary
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This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.

Detailed Description
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PRIMARY OBJECTIVES: I. Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients review decision aid. GROUP II: Patients receive standard of care. After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.

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

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Health Promotion and Education
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AIM 1: Suspected lung cancer AIM 1: English fluency AIM 1: > 6-month life expectancy AIM 1: Score of > 3 on the cognitive impairment screener AIM 2 PARTICIPANTS: Participation in Aim 1 AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants VA-SPECIFIC REQUIREMENT (inclusion of non-Veterans): Non-Veterans will be recruited for this study. Non-Veterans are an important component to this project since they will provide outside perspective. In this way, results of this study will be more generalizable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (decision aid)<br>Patients review decision aid. | Other: Health Promotion and Education<br>* View decision aid<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (standard of care)<br>Patients receive standard of care. | Other: Best Practice<br>* Receive standard of care<br>* Other names: standard therapy;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Satisfaction | Will be assessed using two scales: 1) The Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict. 2) The Decisional Self-Efficacy Scale, which contains 11 items. Higher scores indicate higher self-efficacy. | Up to 6 months | 
| Efficacy of a conversation tool on patients' knowledge of lung cancer | Will be assessed using nine questions from previously validated measures. | Up 6 months | 
| Satisfaction with Communication/Confidence in Decision | Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy -- Lung scale | Will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life. | Up to 6 months. | 
| Depression/Anxiety | Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression. | Up to 6 months | 
| Participation in Decision-Making | Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as patient controlled, answers of 3 are categorized as shared, and answers of 4 or 5 are categorized as physician-controlled. | Up to 6 months | 
| Decision Regret | Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret. | Up to 6 months | 
| Quality of Communication | Will be assessed using the  30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication. | Up to 6 months | 
| Number of Palliative Care Referrals | Will be assessed by conducting chart review | Up to 6 months | 
| Treatment Decision-Making Concordance | Will be assessed by observing the treatment received and the treatment most aligned with responses to the conversation tool. If the treatment received is the same treatment the patient preferred according to the conversation tool, the treatment decision will be considered concordant. | Up to 6 months | 
| Acceptability | Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only. | Up to 6 months |