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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03944265
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
33.7
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Other: Counseling
  • Other: Questionnaire Administration
  • Other: Medical Chart Review
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. Pilot test the adapted DCP in a subset of patients to determine the feasibility of delivering the DCP session.

  2. 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
Allocation:
N/A
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 :
Feb 8, 2019
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Dec 1, 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 Names:
  • Counseling Intervention

    • Other: Questionnaire Administration
    Ancillary studies

    Other: Medical Chart Review
    Ancillary studies
    Other Names:
  • Chart Review

    		•

    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 [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT03944265
    Other Study ID Numbers:
    • 18C.584
    First Posted:
    May 9, 2019
    Last Update Posted:
    Jun 4, 2021
    Last Verified:
    Jun 1, 2021
    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

    Study Results

    No Results Posted as of Jun 4, 2021