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

NCT03944265 | Completed

• 2 other identifiers: 18C.584JT 13163
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Development of materials and methods to adapt an existing decision counseling program (DCP) for use with patients diagnosed with advanced non-small cell lung cancer as a standard component of clinical care

  Results will be reported descriptively. A Decision Counseling Program (DCP) is a tool that allows patients and physicians to engage shared decision making. The DCP will be created based on genetic tumor diagnostics, provider treatment recommendations, and feedback from patients and providers gathered from interviews.

  Up to 6 weeks

Secondary Outcomes (3)

• Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP

  Up to 6 weeks

• DCP effects on patient treatment knowledge and decisional conflict

  Up to 60 days

• Treatment choice of patients after receiving counseling

  Up to 60 days

Study Arms (1)

Supportive care (treatment decision counseling session)

EXPERIMENTAL

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.

Other: Counseling; Other: Questionnaire Administration; Other: Medical Chart Review

Interventions

Counseling OTHER

Participate in treatment decision counseling session

Also known as: Counseling Intervention

Supportive care (treatment decision counseling session)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (treatment decision counseling session)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Supportive care (treatment decision counseling session)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Neal Flomenberg, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 9, 2019
• Study Start: February 8, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)