Condition or disease | Intervention/treatment | Phase |
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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 |
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 Type : | Interventional (Clinical Trial) |
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 : | February 8, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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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.
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Other: Counseling
Participate in treatment decision counseling session
Other Name: Counseling Intervention
Other: Questionnaire Administration Ancillary studies
Other: Medical Chart Review Ancillary studies
Other Name: Chart Review
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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]
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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.
United States, Pennsylvania | |
Sidney Kimmel Cancer Center at Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Neal Flomenberg, MD | Sidney Kimmel Cancer Center at Thomas Jefferson University |
Tracking Information | |||||
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First Submitted Date ICMJE | April 24, 2019 | ||||
First Posted Date ICMJE | May 9, 2019 | ||||
Last Update Posted Date | June 4, 2021 | ||||
Actual Study Start Date ICMJE | February 8, 2019 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer | ||||
Official Title ICMJE | Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study | ||||
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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
14 | ||||
Original Estimated Enrollment ICMJE |
60 | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03944265 | ||||
Other Study ID Numbers ICMJE | 18C.584 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Thomas Jefferson University | ||||
Study Sponsor ICMJE | Thomas Jefferson University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Thomas Jefferson University | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |