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

OHSU Knight Cancer Institute

Status: Enrolling

Conditions: Lung Carcinoma

Treatments: Other: Questionnaire Administration; Other: Health Promotion and Education; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT05407168

NCI-2021-09819 (Registry Identifier)

STUDY00023160 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Group I (decision aid)

Experimental group

Description:

Patients review decision aid.

Treatment:

Other: Health Promotion and Education

Other: Questionnaire Administration

Group II (standard of care)

Active Comparator group

Description:

Patients receive standard of care.

Treatment:

Other: Best Practice

Other: Questionnaire Administration