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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-13900 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21CA259985 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (video) | Experimental | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Behavioral | Participate in a video intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Message-specific Knowledge/Recall Accuracy | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Genomic Knowledge | Measured with the validated 10 true/false question survey that measure objective knowledge of genes/genetics (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel G Stover, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States | ||
| St. Rita's |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38106014 | Derived | Veney D, Wei L, Toland AE, Presley CJ, Hampel H, Padamsee TJ, Lee CN, Irvin WJ Jr, Bishop M, Kim J, Hovick SR, Senter L, Stover DG. A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Cancer. medRxiv [Preprint]. 2023 Dec 5:2023.12.05.23299443. doi: 10.1101/2023.12.05.23299443. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1- Breast | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2023 |
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| Questionnaire Administration |
| Other |
Complete questionnaires |
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| Patient Trust of Physician/Provider | Measured with the 11-item trust in physician/provider survey (TIPP). The survey uses a 5-point Likert scale with scores ranging from 11 to 55, with higher scores indicating greater trust in physician/provider. Will be summarized using descriptive statistics. | 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 | 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. | 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 | Measured with the 11-item trust in physician/provider survey (TIPP). The survey uses a 5-point Likert scale with scores ranging from 11 to 55, with higher scores indicating greater trust in physician/provider.. 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. | 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) |
| Lima |
| Ohio |
| 45801 |
| United States |
| Saint Francis Medical Center | Richmond | Ohio | 23222 | United States |
| Saint Elizabeth Youngstown Hospital | Youngstown | Ohio | 44504 | United States |
| Cohort 2- Lung |
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| FG002 | Cohort 3- Other Cancer | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| FG003 | Cohort 4- Community | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| Enrolled and initiated T1 survey participation |
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| Completed T2 survey participation |
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| Completed T3 survey participation |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1- Breast | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| BG001 | Cohort 2- Lung | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| BG002 | Cohort 3- Other | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| BG003 | Cohort 4- Community | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Message-specific Knowledge/Recall Accuracy | 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. | Number of participants analyzed includes all participants who completed all three time points of the study. | Posted | Mean | Inter-Quartile Range | Percent of questions answered correctly | 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) |
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| Secondary | Patient Genomic Knowledge | Measured with the validated 10 true/false question survey that measure objective knowledge of genes/genetics (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. | Number of participants analyzed includes all participants who completed all three time points of the study. | Posted | Median | Inter-Quartile Range | Percent of questions answered correctly | 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) |
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| Secondary | Patient Trust of Physician/Provider | Measured with the 11-item trust in physician/provider survey (TIPP). The survey uses a 5-point Likert scale with scores ranging from 11 to 55, with higher scores indicating greater trust in physician/provider. Will be summarized using descriptive statistics. | Number of participants analyzed includes all participants who completed all three time points of the study. | Posted | Median | Inter-Quartile Range | score on a scale | 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) |
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| Secondary | 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. | Only breast cancer and lung cancer cohorts were analyzed for this outcome measure | Posted | Median | Inter-Quartile Range | Percent of questions answered correctly | 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) |
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| Secondary | Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients | Measured with the 11-item trust in physician/provider survey (TIPP). The survey uses a 5-point Likert scale with scores ranging from 11 to 55, with higher scores indicating greater trust in physician/provider.. 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. | Only breast cancer and lung cancer cohorts were analyzed for this outcome measure | Posted | Median | Inter-Quartile Range | score on a scale | 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) |
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Adverse events were not collected
Adverse Events were not collected for this study. Due to the minimal risk of the study intervention (watching an educational video and responding to surveys), it was not prespecified to collect any adverse event data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel G. Stover | Ohio State University Comprehensive Cancer Center | (614) 685-6700 | Daniel.Stover@osumc.edu |
| Mar 9, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2023 | Mar 9, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Black or African American |
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| Hispanic or Latino or Spanish |
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| Asian |
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| American Indian or Alaska Native |
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| Other Race or Ethnicity |
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| Prefer not to answer |
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| T2 (After participating in video intervention) |
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| T3 (After receiving NGS results) |
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Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| OG003 | Cohort 4- Community | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
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Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
| OG003 | Cohort 4- Community | Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. Health Education: Participate in a video intervention Questionnaire Administration: Complete questionnaires |
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