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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04946279
• Other study ID #: STUDY00020688
• Secondary ID: NCI-2021-05887ST
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Other:
• Best Practice
Receive usual/standard of care
• Informational Intervention
Receive conversation tool
• Questionnaire Administration
Ancillary studies - Baseline and follow-up questionnaires

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	ATS Foundation, Hildegard Lamfrom Endowment, Medical Research Foundation, Oregon, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the conversation tool	The number of patients enrolled divided by the number of patients offered enrollment.	At enrollment
Primary	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	Anxiety	Assessed using the Hospital Anxiety and Depression Scale.	From enrollment to the end of follow-up at 8 weeks
Secondary	Decisional conflict	Assessed using the Decisional Conflict Scale.	At the end of follow-up at 8 weeks
Secondary	Decisional Regret	Assessed using the Decisional Regret Scale.	At the end of follow-up at 8 weeks
Secondary	Perceived involvement in care	Assessed using the Perceived Involvement in Care Scale.	At the end of follow-up at 8 weeks
Secondary	Shared decision-making quality	Assessed using the Shared Decision Making Questionnaire.	At the end of follow-up at 8 weeks
Secondary	Decision making involvement	Assessed using the Control Preferences Scale.	From enrollment to the end of follow-up at 8 weeks
Secondary	Self-efficacy	Assessed using the Decision Self-Efficacy Scale.	From enrollment to the end of follow-up at 8 weeks
Secondary	Values-treatment concordance	Assessed using electronic medical record (EMR).	From enrollment to the end of follow-up at 8 weeks