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

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

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.

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.

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.

Will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.

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.

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."

Will be assessed using the ~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.

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.

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