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

Not Applicable

Recruiting

• Conditions: Lung Carcinoma

• Registration Number: NCT05407168
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-10-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decision Conflict	Up to 6 months	Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.
Efficacy of a conversation tool on patients' knowledge of lung cancer	Up 6 months	Will be assessed using nine questions from previously validated measures.
Satisfaction with Communication/Confidence in Decision	Up to 6 months	Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.
Self-Efficacy	Up to 6 months	Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.

Secondary Outcome Measures

Name	Time	Method
FACT-L	Up to 6 months.	Quality of Life will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.
Depression/Anxiety	Up to 6 months	Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression.
Participation in Decision-Making	Up to 6 months	Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as "patient controlled", answers of 3 are categorized as "shared", and answers of 4 or 5 are categorized as "physician-controlled."
Decision Regret	Up to 6 months	Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.
Quality of Communication	Up to 6 months	Will be assessed using the \~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.
Number of Palliative Care Referrals	Up to 6 months	Will be assessed by conducting chart review
Treatment Decision-Making Concordance	Up to 6 months	Will be assessed by observing the treatment received and the treatment most aligned with responses to the conversation tool. If the treatment received is the same treatment the patient preferred according to the conversation tool, the treatment decision will be considered concordant.
Acceptability	Up to 6 months	Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.

Trial Locations

Locations (4)

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