Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
Overview
- Phase
- N/A
- Intervention
- Health Education
- Conditions
- Not specified
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Enrollment
- 243
- Locations
- 7
- Primary Endpoint
- Message-specific knowledge/recall accuracy
- Status
- Active, Not Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
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
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.
Investigators
Daniel Stover
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
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
Arms & Interventions
Health services research (video)
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Intervention: Health Education
Health services research (video)
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Message-specific knowledge/recall accuracy
Time Frame: Immediately before and immediately after video intervention
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.
Message-specific Knowledge/Recall Accuracy
Time Frame: At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline)
Measured as percentage 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.
Secondary Outcomes
- Change in patient trust of physician/provider in MBC versus MLC patients(Immediately before and immediately after video intervention)
- Change in patient trust of physician/provider(Immediately before and immediately after video intervention)
- Change in patient genomic knowledge(Immediately before and immediately after video intervention)
- Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients(Immediately before and immediately after video intervention)
- Patient Genomic Knowledge(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Patient Trust of Physician/Provider(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))
- Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients(At T1 (baseline), at T2 (within 27-days of baseline, all following video viewing and on the same date as video viewing), and at T3 (Up to 288 days after baseline))