Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Receive education on precision medicine

• Registration Number: NCT05795959
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-04-20
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-08
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Receive education on precision medicine	Participants randomized to this arm of the study will receive usual care with supplemental education and support provided by a lay VA volunteer trained on evidence-based lung cancer care.

Primary Outcome Measures

Name	Time	Method
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment	Baseline	Using 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 Outcome Measures

Name	Time	Method
Patient activation using the "Patient Activation Measure" survey	1 month post-enrollment	Each patient will receive a validated patient activation survey using the "Patient Activation Measure" at 1 month post-enrollment. 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 1 month post-enrollment
Receipt of molecular testing	6 months post-enrollment	Chart review will be used to abstract whether participants received molecular testing
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey	1 month post-enrollment	Using 9 items of the validated 9-item Shared Decision Making Questionnaire (SDM-Q-9) at 1 month post-enrollment. 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 targeted therapy for those with an eligible molecular target	6 months post-enrollment	Chart review will be used to abstract whether participants with a molecular target received targeted treatment for the molecular target

Trial Locations

Locations (1)

VA Palo Alto; 🇺🇸 Palo Alto, California, United States