Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
NCT ID: NCT05407168
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2022-10-31
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Group I (decision aid)
Patients review decision aid.
Health Promotion and Education
View decision aid
Questionnaire Administration
Ancillary studies
Group II (standard of care)
Patients receive standard of care.
Best Practice
Receive standard of care
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive standard of care
Health Promotion and Education
View decision aid
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
American Cancer Society, Inc.
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Donald R Sullivan, MD, MA, MCR
Principal Investigator
Principal Investigators
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Donald R Sullivan, MD, MA, MCR
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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Hillsboro Medical Center
Hillsboro, Oregon, United States
Adventist Health Portland
Portland, Oregon, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Portland VA Medical Center
Portland, Oregon, United States
Countries
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Facility Contacts
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References
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Disher N, Dieckmann NF, Case JR, Rubim F, Eden KB, Golden SE, Matlock DD, Coleman C, Lyons KS, Saha S, Slatore CG, Vranas KC, Sullivan DR. Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial. Future Oncol. 2025 Apr;21(9):1045-1056. doi: 10.1080/14796694.2025.2475733. Epub 2025 Mar 18.
Other Identifiers
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NCI-2021-09819
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00023160
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00023160
Identifier Type: -
Identifier Source: org_study_id
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