Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer

Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool

This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8
• Intervention / Treatment: Other: Informational Intervention; Other: Questionnaire Administration; Other: Best Practice

Detailed Description

PRIMARY OBJECTIVES:

I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.

II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive the conversation tool.

ARM II: Patients receive usual care.

Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
    • Portland, Oregon, United States, 97239
      • Portland VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
• PART I: English fluency
• PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
• PART II: English fluency
• PART II: > 6-month life expectancy
• PART II: Score of > 3 on the 6-Item Screener for Cognitive Impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (conversation tool); Patients receive the conversation tool.	Other: Informational Intervention; Receive conversation tool; Other: Questionnaire Administration; Ancillary studies - Baseline and follow-up questionnaires
Active Comparator: Arm II (usual care); Patients receive usual care.	Other: Questionnaire Administration; Ancillary studies - Baseline and follow-up questionnaires; Other: Best Practice; Receive usual/standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the conversation tool	The number of patients enrolled divided by the number of patients offered enrollment.	At enrollment
Acceptability of the conversation tool	The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Assessed using the Hospital Anxiety and Depression Scale.	From enrollment to the end of follow-up at 8 weeks
Decisional conflict	Assessed using the Decisional Conflict Scale.	At the end of follow-up at 8 weeks
Decisional Regret	Assessed using the Decisional Regret Scale.	At the end of follow-up at 8 weeks
Perceived involvement in care	Assessed using the Perceived Involvement in Care Scale.	At the end of follow-up at 8 weeks
Shared decision-making quality	Assessed using the Shared Decision Making Questionnaire.	At the end of follow-up at 8 weeks
Decision making involvement	Assessed using the Control Preferences Scale.	From enrollment to the end of follow-up at 8 weeks
Self-efficacy	Assessed using the Decision Self-Efficacy Scale.	From enrollment to the end of follow-up at 8 weeks
Values-treatment concordance	Assessed using electronic medical record (EMR).	From enrollment to the end of follow-up at 8 weeks

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Medical Research Foundation, Oregon; ATS Foundation; Hildegard Lamfrom Endowment
• Investigators: Principal Investigator: Donald Sullivan, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Guidelines as Topic; Quality Assurance, Health Care; Standard of Care; Practice Guidelines as Topic
• Other Study ID Numbers: STUDY00020688 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-05887 (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
• product manufactured in and exported from the U.S.: No