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

NCT ID: NCT03944265

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2020-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (treatment decision counseling session)

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.

Group Type: EXPERIMENTAL

Counseling

Intervention Type: OTHER

Participate in treatment decision counseling session

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Medical Chart Review

Intervention Type: OTHER

Ancillary studies

Interventions

Counseling

Participate in treatment decision counseling session

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Medical Chart Review

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Counseling Intervention; Chart Review

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed with advanced NSCLC (stage IV a-c) that are wild-type for activating genetic alterations (EGFR, ROS 1, and ALK).
• May or may not be candidates for immune checkpoint therapy.
• May have had 1-any number of prior systemic therapy regimens.
• If prior systemic regimen, must have progression disease at time of evaluation.
• Untreated brain metastases permitted.
• Completed pathological analysis of tumor tissue.
• Patients who have exhausted targeting therapy options.
• Can speak and read English.
• All participants must be willing to comply with all study procedures and be available for the duration of the study.
• Providers: Those who treat NSCLC patients as described above.

Exclusion Criteria

• There are no specific exclusions in this trial for particular medical conditions, comorbidities, or performance status. Any patient deemed appropriate to be considered for evaluation and/or treatment would be appropriate to include in this trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal Flomenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Cancer Center at Thomas Jefferson University

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 13163

Identifier Type: OTHER

Identifier Source: secondary_id

18C.584

Identifier Type: -

Identifier Source: org_study_id