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

OHSU Knight Cancer Institute

Status: Active, not recruiting

Conditions: Stage I Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8

Treatments: Other: Informational Intervention; Other: Best Practice; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT04946279

STUDY00020688 (Other Identifier)

NCI-2021-05887 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Arm I (conversation tool)

Experimental group

Description:

Patients receive the conversation tool.

Treatment:

Other: Questionnaire Administration

Other: Informational Intervention

Arm II (usual care)

Active Comparator group

Description:

Patients receive usual care.

Treatment:

Other: Questionnaire Administration

Other: Best Practice