NCT05215769

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

Active, enrolled NA Results posted Last updated 13 April 2026

What this trial tests

NA trial testing Health Education in Anatomic Stage IV Breast Cancer AJCC v8 in 243 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 March 2022

Primary endpoint
27 January 2025

31 July 2026

Quick facts

Lead sponsor	Ohio State University Comprehensive Cancer Center
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	243
Start date	30 March 2022
Primary completion	27 January 2025
Estimated completion	31 July 2026
Sites	4 locations across United States

Drugs / interventions tested

• Health Education
• Questionnaire Administration

Conditions studied

• Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
• Metastatic Breast Carcinoma — all drugs for Metastatic Breast Carcinoma →
• Metastatic Lung Carcinoma — all drugs for Metastatic Lung Carcinoma →
• Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →

Sponsor

Ohio State University Comprehensive Cancer Center

Who can join

18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Metastatic Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Message-specific Knowledge/Recall Accuracy Primary · 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.

T1 (Baseline)

Group	Value	95% CI
Cohort 1- Breast	88.8	80 – 100
Cohort 2- Lung	85.53	80 – 100
Cohort 3- Other	88.0	80 – 100
Cohort 4- Community	85.38	80 – 100

T2 (After participating in video intervention)

Group	Value	95% CI
Cohort 1- Breast	96.8	100 – 100
Cohort 2- Lung	92.67	90 – 100
Cohort 3- Other	95.0	90 – 100
Cohort 4- Community	91.73	90 – 100

T3 (After receiving NGS results)

Group	Value	95% CI
Cohort 1- Breast	91.4	90 – 100
Cohort 2- Lung	89.59	90 – 100
Cohort 3- Other	92.0	90 – 100
Cohort 4- Community	91.15	90 – 100

Patient Genomic Knowledge Secondary · 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 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.

T1 (Baseline)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 100
Cohort 2- Lung	90	80 – 90
Cohort 3- Other	90	80 – 100
Cohort 4- Community	80	70 – 90

T2 (After participating in video intervention)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 100
Cohort 2- Lung	90	80 – 100
Cohort 3- Other	90	80 – 100
Cohort 4- Community	90	80 – 90

T3 (After receiving NGS results)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 90
Cohort 2- Lung	90	80 – 90
Cohort 3- Other	90	80 – 97.5
Cohort 4- Community	90	80 – 90

Patient Trust of Physician/Provider Secondary · 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 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.

T1 (Baseline)

Group	Value	95% CI
Cohort 1- Breast	50.5	44.25 – 53
Cohort 2- Lung	46.22	42.13 – 53.88
Cohort 3- Other	50	43.25 – 52.00
Cohort 4- Community	44.5	39 – 52

T2 (After participating in video intervention)

Group	Value	95% CI
Cohort 1- Breast	51	45 – 54
Cohort 2- Lung	48	40 – 52.88
Cohort 3- Other	50	45 – 53
Cohort 4- Community	45	41.5 – 52.5

T3 (After receiving NGS results)

Group	Value	95% CI
Cohort 1- Breast	50	47 – 53
Cohort 2- Lung	50	45 – 53
Cohort 3- Other	49.5	43 – 53
Cohort 4- Community	45	41.75 – 51

Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients Secondary · 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 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.

T1 (Baseline)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 100
Cohort 2- Lung	90	80 – 90

T2 (After participating in video intervention)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 100
Cohort 2- Lung	90	80 – 100

T3 (After receiving NGS results)

Group	Value	95% CI
Cohort 1- Breast	90	80 – 90
Cohort 2- Lung	90	80 – 90

Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients Secondary · 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 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.

T1 (Baseline)

Group	Value	95% CI
Cohort 1- Breast	50.5	44.25 – 53
Cohort 2- Lung	46.22	42.13 – 53.88

T2 (After participating in video intervention)

Group	Value	95% CI
Cohort 1- Breast	51	45 – 54
Cohort 2- Lung	48	40 – 52.88

T3 (After receiving NGS results)

Group	Value	95% CI
Cohort 1- Breast	50	47 – 53
Cohort 2- Lung	50	45 – 53

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A video intervention to improve patient understanding of tumor genomic testing in patients with cancer.
   Veney DJ, Wei LY, Toland AE, Presley CJ, et al · · 2024 · cited 1× · PMID 39258462 · DOI 10.1002/cam4.70095
2. A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients with Cancer
   Veney D, Wei L, Toland AE, Presley CJ, et al · · 2023 · DOI 10.1101/2023.12.05.23299443