4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer

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

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
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

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
Layout table for study information
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
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 Name: Counseling Intervention

Other: Questionnaire Administration
Ancillary studies

Other: Medical Chart Review
Ancillary studies
Other Name: 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 [ 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
Layout table for eligibility information
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

Locations
Layout table for location information
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Layout table for investigator information
Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
Tracking Information
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
 (submitted: May 8, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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.
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.

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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
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:
  • Other: Counseling
  • Other: Questionnaire Administration
  • Other: Medical Chart Review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019)
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:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Neal Flomenberg, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
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

治疗医院