- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03944265
Recruitment Status Active, not recruiting
First Posted May 9, 2019
Last update posted May 28, 2020
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.
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.
|Experimental: 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.
Participate in treatment decision counseling session
Other: Questionnaire Administration
Other: Medical Chart Review
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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.
• 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.
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Thomas Jefferson University
Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University