NCT05407168

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Lung Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Health Promotion and Education	View decision aid
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2022-10-31
• Primary completion: 2026-09-30
• Completion: 2027-12-31
• First posted: 2022-06-07
• Last updated: 2025-04-09

Locations

4 sites across 1 country: United States