Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT05407168
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2021-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iDECIDE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: