Clinical trial NCT03944265: Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer
Official title: Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 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
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP
timeFrame: Up to 6 weeks
measure: DCP effects on patient treatment knowledge and decisional conflict
timeFrame: Up to 60 days
measure: Treatment choice of patients after receiving counseling
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Neal Flomenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: