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

Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Health Promotion and Education

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Recruiting
      • Hillsboro Medical Center
      • Contact: Donald Sullivan, MD, MA, MCR; Phone Number: 58087 503-220-8262; Email: sullivad@ohsu.edu
      • Principal Investigator: Donald Sullivan, MD, MA, MCR
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Donald R Sullivan, MD, MA, MCR; Phone Number: 58087 503-220-8262; Email: sullivad@ohsu.edu
      • Principal Investigator: Donald R Sullivan, MD, MA, MCR
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Portland VA Medical Center
      • Contact: Donald R Sullivan, MD, MA, MCR; Phone Number: 58087 503-220-8262; Email: sullivad@ohsu.edu
      • Principal Investigator: Donald R Sullivan, MD, MA, MCR
    • Portland, Oregon, United States, 97216
      • Recruiting
      • Adventist Health Portland
      • Contact: Donald Sullivan, MD, MA, MCR; Phone Number: 58087 503-220-8262; Email: sullivad@ohsu.edu
      • Principal Investigator: Donald Sullivan, MD, MA, MCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• VA-SPECIFIC REQUIREMENT (inclusion of non-Veterans): Non-Veterans will be recruited for this study. Non-Veterans are an important component to this project since they will provide outside perspective. In this way, results of this study will be more generalizable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (decision aid); Patients review decision aid.	Other: Questionnaire Administration; Ancillary studies; Other: Health Promotion and Education; View decision aid
Active Comparator: Group II (standard of care); Patients receive standard of care.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision Satisfaction	Will be assessed using two scales: 1) The Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict. 2) The Decisional Self-Efficacy Scale, which contains 11 items. Higher scores indicate higher self-efficacy.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy -- Lung scale	Will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.	Up to 6 months.
Depression/Anxiety	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.	Up to 6 months
Participation in Decision-Making	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."	Up to 6 months
Decision Regret	Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.	Up to 6 months
Quality of Communication	Will be assessed using the ~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.	Up to 6 months
Number of Palliative Care Referrals	Will be assessed by conducting chart review	Up to 6 months
Treatment Decision-Making Concordance	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.	Up to 6 months
Acceptability	Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.	Up to 6 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; American Cancer Society, Inc.
• Investigators: Principal Investigator: Donald R Sullivan, MD, MA, MCR, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: STUDY00023160 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-09819 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No