Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

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

Counseling

Questionnaire Administration

Medical Chart Review

Neal Flomenberg, MD

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.

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

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.

Results will be reported descriptively. The feasibility endpoint will be the proportion of consenting patients who complete the DCP, about which we will estimate an exact 95% confidence interval by the Clopper-Pearson method.

Results will be reported descriptively on pre and post surveys that will be completed by patients Survey is the Decisional Conflict Scale (DCS) Total and subscores have applicable items are a) summed; b) divide by 10; and c) multiplied by 25 Total Score Items 1-10 Score range: 0 \[No decisional conflict\] to 100 \[extremely high decisional conflict\].

Uncertainty Sub score Items 9, 10 Score range: 0 \[feels extremely certain about best choice\] to 100 \[feels extremely uncertain about best choice\] Informed Sub score Items 1, 2, 3 Score range: 0 \[feels extremely informed\] to 100 \[feels extremely uninformed\].

Values Clarity Sub score Items 4, 5 Score range: 0 \[feels extremely clear about person; a values for benefits and risks/side effects\] to 100 \[feels extremely unclear about personal value\] Support Sub score Items 6, 7, 8 Score range: 0 \[feels extremely supported in decision making\] to 100 \[feels extremely unsupported in decision making\]

Results will be reported descriptively. Will be collected on pre and post surveys that will be completed by patients. Overall summary statistics will be computed for the patient surveys. Medical records data will be reviewed in order to determine the patient treatment regimen.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer	NCT03944265	Activating ALK ... Activating EGFR... Activating ROS1... Health Care Pro... Lung Non-Small ... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Counseling Questionnaire A... Medical Chart R...	18 Years -	Thomas Jefferson University
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer	NCT03944265	Activating ALK ... Activating EGFR... Activating ROS1... Health Care Pro... Lung Non-Small ... Stage IV Lung C... Stage IVA Lung ... Stage IVB Lung ...	Counseling Questionnaire A... Medical Chart R...	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for activating alk gene mutation negative