Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03944265|
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Counseling Other: Questionnaire Administration Other: Medical Chart Review||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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 8, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
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 Name: Counseling Intervention
Other: Questionnaire Administration
Other: Medical Chart Review
Other Name: Chart Review
- 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.
- 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.
- 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]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944265
|Contact: Neal Flomenberg, MDemail@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Neal Flomenberg|
|Principal Investigator:||Neal Flomenberg, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|