About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03944265

Recruitment Status Active, not recruiting

First Posted May 9, 2019

Last update posted May 28, 2020

Study Description

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.

  • Condition or Disease:Activating ALK Gene Mutation Negative
    Activating EGFR Gene Mutation Negative
    Health Care Provider
    Activating ROS1 Gene Mutation Negative
    Lung Non-Small Cell Carcinoma
    Stage IV Lung Cancer AJCC v8
    Stage IVA Lung Cancer AJCC v8
    Stage IVB Lung Cancer AJCC v8
  • Intervention/Treatment: Other: Counseling
    Other: Questionnaire Administration
    Other: Medical Chart Review
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 14 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: February 2021
Arms and interventions
Arm Intervention/treatment
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.
Other: Counseling
Participate in treatment decision counseling session

Other: Questionnaire Administration
Ancillary studies

Other: Medical Chart Review
Ancillary studies
Outcome Measures
  • Primary Outcome Measures: 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 [ Time Frame: Up to 6 weeks ]
    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.
  • Secondary Outcome Measures: 1. Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP [ Time Frame: Up to 6 weeks ]
    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.
  • 2. DCP effects on patient treatment knowledge and decisional conflict [ Time Frame: Up to 60 days ]
    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]
  • 3. Treatment choice of patients after receiving counseling [ Time Frame: Up to 60 days ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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.

Contacts and Locations
Contacts
Locations

United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University

More Information
  • Responsible Party: Thomas Jefferson University
  • ClinicalTrials.gov Identifier: NCT03944265 History of Changes
  • Other Study ID Numbers: 18C.584
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 28, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lung Neoplasms Carcinoma, Non-Small-Cell Lung