Activating ALK Gene Mutation NegativeNCT03944265
Genetics and Shared Decision Making in Improving Care for Patients With Stage IVA-C Non-small Cell Lung Cancer
A study testing Counseling, Questionnaire Administration and Medical Chart Review in people with Activating ALK Gene Mutation Negative and Activating EGFR Gene Mutation Negative, run by Thomas Jefferson University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Activating ALK Gene Mutation Negative, Activating EGFR Gene Mutation Negative, Activating ROS1 Gene Mutation Negative
- What is being tested?
- Counseling, Questionnaire Administration and Medical Chart Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- 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
- Being tested
- Counseling, Questionnaire Administration, Medical Chart Review
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingOther
Also called Counseling Intervention
Participate in treatment decision counseling session
Questionnaire AdministrationOther
Ancillary studies
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (treatment decision counseling session) | Experimental | 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. Receives: Other: Counseling; Other: Questionnaire Administration; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Up to 6 weeks
Secondary outcomes (3)
Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP
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.
Measured: Up to 6 weeks
DCP effects on patient treatment knowledge and decisional conflict
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]
Measured: Up to 60 days
Treatment choice of patients after receiving counseling
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.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start8 Feb 2019
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activating ALK Gene Mutation NegativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neal Flomenberg, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944265
- Sponsor's protocol ID
- 18C.584
- Other IDs
- JT 13163
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2019
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Genetics and Shared Decision Making to Improve Lung Cancer Care: A Developmental Study
- ClinicalTrials.gov ID
- NCT03944265
- Acronym / sponsor ID
- 18C.584
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (treatment decision counseling session) | Experimental | Other: Counseling, Other: Questionnaire Administration, Other: Medical Chart ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Counseling InterventionParticipate in treatment decision counseling session | Other | Supportive care (treatment decision counseling session) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (treatment decision counseling session) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Supportive care (treatment decision counseling session) |
Primary outcome
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.
3 secondary outcomes
Feasibility of the adapted DCP in a subset of patients: proportion of consenting patients who complete the DCP
Time frame: Up to 6 weeks
DCP effects on patient treatment knowledge and decisional conflict
Time frame: Up to 60 days
Treatment choice of patients after receiving counseling
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Flomenberg, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Questionnaire Administration and Medical Chart Review in people with Activating ALK Gene Mutation Negative and Activating EGFR Gene Mutation Negative, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.