Clinical trial NCT05407168: Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
Official title: Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: American Cancer Society, Inc.
First posted: 2022-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decision Conflict
timeFrame: Up to 6 months
measure: Efficacy of a conversation tool on patients' knowledge of lung cancer
timeFrame: Up 6 months
measure: Satisfaction with Communication/Confidence in Decision
timeFrame: Up to 6 months
measure: Self-Efficacy
timeFrame: Up to 6 months
Secondary outcomes:
measure: FACT-L
timeFrame: Up to 6 months.
measure: Depression/Anxiety
timeFrame: Up to 6 months
measure: Participation in Decision-Making
timeFrame: Up to 6 months
measure: Decision Regret
timeFrame: Up to 6 months
measure: Quality of Communication
timeFrame: Up to 6 months
measure: Number of Palliative Care Referrals
timeFrame: Up to 6 months
measure: Treatment Decision-Making Concordance
timeFrame: Up to 6 months
measure: Acceptability
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Hillsboro
country: United States
facility: Hillsboro Medical Center
state: Oregon
city: Portland
country: United States
facility: Adventist Health Portland
state: Oregon
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Donald R Sullivan, MD, MA, MCR
role: PRINCIPAL_INVESTIGATOR
References: