A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer

Study Overview
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Brief Summary
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This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess change in patient knowledge about tumor next generation sequencing (NGS) following exposure to the video. SECONDARY OBJECTIVES: I.To assess changes following exposure to the video, including; Ia. Genomic knowledge via the validated 10 true/false question survey (% correct out of 10). Ib. 11-item Trust in Physician Survey (TPS) as a single TPS score. Ic. Comparison of results in three patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) metastatic cancer of unspecified type. EXPLORATORY OBJECTIVE: I. Assess whether therapies prescribed as a result of tumor NGS achieved clinically favorable result through chart review. OUTLINE: Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.

Official Title
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Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing

Conditions
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Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Solid Neoplasm, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

Intervention / Treatment
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* Behavioral: Health Education
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have biopsy-confirmed metastatic cancer Be >= 18 years of age Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS Exclusion Criteria: Exclude patients who are not English- or Spanish-speaking

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health services research (video)<br>Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. | Behavioral: Health Education<br>* Participate in a video intervention<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Message-specific knowledge/recall accuracy | Measured as number correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05. | Immediately before and immediately after video intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient genomic knowledge | Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. | Immediately before and immediately after video intervention | 
| Change in patient trust of physician/provider | Measured with the 11-item trust in physician survey (TPS) as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. | Immediately before and immediately after video intervention | 
| Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients | Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test. | Immediately before and immediately after video intervention | 
| Change in patient trust of physician/provider in MBC versus MLC patients | Measured with the 11-item TPS as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test. | Immediately before and immediately after video intervention |