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

NCT ID: NCT05407168

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2027-12-31

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.

Conditions

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Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group I (decision aid)

Patients review decision aid.

Group Type EXPERIMENTAL

Health Promotion and Education

Intervention Type OTHER

View decision aid

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (standard of care)

Patients receive standard of care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Health Promotion and Education

View decision aid

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Donald R Sullivan, MD, MA, MCR

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Adventist Health Portland

Portland, Oregon, United States

Site Status RECRUITING

OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status RECRUITING

Portland VA Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Donald Sullivan, MD, MA, MCR

Role: primary

503-220-8262 ext. 58087

Donald Sullivan, MD, MA, MCR

Role: primary

503-220-8262 ext. 58087

Donald R Sullivan, MD, MA, MCR

Role: primary

503-220-8262 ext. 58087

Donald R Sullivan, MD, MA, MCR

Role: primary

503-220-8262 ext. 58087

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.

Reference Type DERIVED
PMID: 40098532 (View on PubMed)

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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