Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Receive education on precision medicine

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Receive 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.
No Intervention: Control; Participants randomized to this arm of the study will receive usual clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of precision medicine for cancer care from time of enrollment to 1 month post-enrollment	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of molecular testing	Chart review will be used to abstract whether participants received molecular testing	6 months post-enrollment
Receipt of targeted therapy for those with an eligible molecular target	Chart review will be used to abstract whether participants with a molecular target received targeted treatment for the molecular target	6 months post-enrollment
Patient activation using the "Patient Activation Measure" survey	Each 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.	Baseline
Patient activation using the "Patient Activation Measure" survey	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	1 month post-enrollment
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey	Using 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.	Baseline
Patient Satisfaction With Shared Decision Making using the "Shared Decision Making Questionnaire" Survey	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.	1 month post-enrollment

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Manali I Patel, MD MPH MS, VA Palo Alto

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lung Diseases; Precision Medicine; Lay health worker; Veteran health
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 67785

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No