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Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05795959
Enrollment
46
Registered
2023-04-03
Start date
2023-04-20
Completion date
2024-05-20
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Precision Medicine, Lung Diseases, Lay health worker, Veteran health

Brief summary

The goal of this study is to learn if using a lay VA volunteer, who will assist patients with education regarding precision medicine, can improve care quality and outcomes for Veteran patients with lung cancer.

Detailed description

Participants in the intervention group will receive 1:1 communication with a lay VA volunteer in addition to their usual clinical care. The lay VA volunteer will provide patients with education about precision medicine and support in their care. Researchers will compare a control group who will receive their usual oncology care as provided by clinical teams at the VA. There will be no change in their care. All participants will be asked to complete a survey at the time of enrollment in the study, and also at 1 month. This survey will measure patient participation in their cancer care, satisfaction with healthcare decisions, and overall questions about knowledge of precision medicine.

Interventions

BEHAVIORALReceive education on precision medicine

Patients who consent to participating in the study and are randomized to the intervention group, will meet 1 on 1 with a trained lay VA volunteer. The trained lay VA volunteer will conduct phone calls with patients until the end of the 1 month enrollment period to deliver education regarding precision medicine.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients 18 years old that have been newly diagnosed with any stage of lung cancer. * Patients must have the ability to understand and willingness to provide verbal consent. * Participants must speak English.

Exclusion criteria

* Inability to consent to the study, severe mental illness (e.g. schizophrenia) or institutionalization. * Patients who anticipate moving care outside the Veterans Affairs Palo Alto Health Care System within 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollmentBaselineUsing 8 multiple choice items adapted from an 8-item survey tool, Knowledge and Purpose of Molecular Profiling, by Davies et. al., 2020, we will assess knowledge of precision medicine for cancer care at time of enrollment and again at 1-month post-enrollment. For example one question asks 'tumor testing is helpful for guiding the treatment of lung cancer,' with answer choices: yes or no. Answers will be scored as number or percent correct.

Secondary

MeasureTime frameDescription
Patient activation using the Patient Activation Measure surveyBaselineEach patient will receive a validated patient activation survey using the Patient Activation Measure at baseline. This is a validated measure from Insignia Health. Responses are: disagree strongly, disagree, agree, agree strongly with higher activation correlated with responses of agree and agree strongly. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional not applicable option). Higher scores indicate greater patient activation. For the PAM-10, minimum score is 0 (if all not-applicable) and maximum is 100. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged at baseline.
Patient Satisfaction With Shared Decision Making using the Shared Decision Making Questionnaire SurveyBaselineUsing 9 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at baseline. Responses are completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, or completely agree, with 1=completely disagree and 6= completely agree. Higher scores indicate greater levels of satisfaction.
Receipt of molecular testing6 months post-enrollmentChart review will be used to abstract whether participants received molecular testing
Receipt of targeted therapy for those with an eligible molecular target6 months post-enrollmentChart review will be used to abstract whether participants with a molecular target received targeted treatment for the molecular target

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026