NCT04946279

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage III Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual/standard of care
OTHER	Informational Intervention	Receive conversation tool
OTHER	Questionnaire Administration	Ancillary studies - Baseline and follow-up questionnaires

Timeline

• Start date: 2020-08-07
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-06-30
• Last updated: 2025-09-05

Locations

2 sites across 1 country: United States