NCT03944265

Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer

Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial studies the use of genetics and shared decision making in improving care for patients with stage IVA-C non-small cell lung cancer. Developing educational tools may help patients with non-small cell lung cancer to increase patient treatment knowledge, reduce decisional conflict, and promote treatment shared decision making with their health care providers.

Detailed description

PRIMARY OBJECTIVES: I. Use the information on genomic tumor diagnostics, provider treatment recommendations, and patient and provider feedback on the treatment decision making process, which will be used to develop materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung carcinoma (NSCLC) as a standard component of clinical care. SECONDARY OBJECTIVES: I. Pilot test the adapted DCP in a subset of patients to determine the feasibility of delivering the DCP session. II. Assess DCP effects on patient treatment knowledge and decisional conflict. III. Assess treatment choice. OUTLINE: PHASE I: Use physician input to develop draft treatment education materials and use patient input to adapt an online decision counseling application for use in helping patients clarify treatment preference. PHASE II: Patients complete a treatment decision counseling session/interview about genetic testing and supportive/palliative care with a qualified member of the research team in-person or via telephone. Health care providers receive a 1-page summary of session results for use in treatment shared decision making at the next office visit. After completion of study, participants are followed up at 30 and 60 days.

Conditions

• Activating ALK Gene Mutation Negative
• Activating EGFR Gene Mutation Negative
• Activating ROS1 Gene Mutation Negative
• Health Care Provider
• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Counseling	Participate in treatment decision counseling session
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Medical Chart Review	Ancillary studies

Timeline

• Start date: 2019-02-08
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2019-05-09
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States