NCT05407168

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2022Dec 2027

First Submitted

Initial submission to the registry

October 5, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

3.9 years

First QC Date

October 5, 2021

Last Update Submit

April 7, 2025

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Decision Conflict

    Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.

    Up to 6 months

  • Efficacy of a conversation tool on patients' knowledge of lung cancer

    Will be assessed using nine questions from previously validated measures.

    Up 6 months

  • Satisfaction with Communication/Confidence in Decision

    Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.

    Up to 6 months

  • Self-Efficacy

    Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.

    Up to 6 months

Secondary Outcomes (8)

  • FACT-L

    Up to 6 months.

  • Depression/Anxiety

    Up to 6 months

  • Participation in Decision-Making

    Up to 6 months

  • Decision Regret

    Up to 6 months

  • Quality of Communication

    Up to 6 months

  • +3 more secondary outcomes

Study Arms (2)

Group I (decision aid)

EXPERIMENTAL

Patients review decision aid.

Other: Health Promotion and EducationOther: Questionnaire Administration

Group II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care.

Other: Best PracticeOther: Questionnaire Administration

Interventions

Best PracticeOTHER

Receive standard of care

Also known as: standard of care, standard therapy
Group II (standard of care)
Health Promotion and EducationOTHER

View decision aid

Group I (decision aid)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (decision aid)Group II (standard of care)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hillsboro Medical Center

Hillsboro, Oregon, 97123, United States

RECRUITING

Adventist Health Portland

Portland, Oregon, 97216, United States

RECRUITING

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40098532DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as TopicStandard of CareHealth PromotionEducational Status

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationQuality Indicators, Health CareHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Donald R Sullivan, MD, MA, MCR

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

June 7, 2022

Study Start

October 31, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

US(4)