Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ensuring Precision-Medicine Delivery for Veterans With Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Receive education on precision medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients >18 years old that have been diagnosed with any stage of lung cancer within the past 8 months are eligible for this study. 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 from the area within 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Participants randomized to this arm of the study will receive usual clinical care. | |

What is the study measuring?
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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 7 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 |
| --- | --- | --- |
| 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 40. 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 40. 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 7 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 7 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Precision Medicine, Lung Diseases, Lay health worker, Veteran health