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

Not Applicable

Active, not recruiting

• Conditions: Stage IV Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma
• Interventions: Other: Informational Intervention; Other: Best Practice; Other: Questionnaire Administration

• Registration Number: NCT04946279
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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.

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 Timeline

• Study Start: 2020-08-07
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 98

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (conversation tool)	Informational Intervention	Patients receive the conversation tool.
Arm I (conversation tool)	Questionnaire Administration	Patients receive the conversation tool.
Arm II (usual care)	Best Practice	Patients receive usual care.
Arm II (usual care)	Questionnaire Administration	Patients receive usual care.

Primary Outcome Measures

Name	Time	Method
Feasibility of the conversation tool	At enrollment	The number of patients enrolled divided by the number of patients offered enrollment.
Acceptability of the conversation tool	At enrollment	The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States