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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Control | No Intervention | Participants randomized to this arm of the study will receive usual clinical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive education on precision medicine | Behavioral | 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. |
| 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 |
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manali I Patel, MD MPH MS | VA Palo Alto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomized controlled trial
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| 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 |
| 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 |
| D012140 |
| Respiratory Tract Diseases |