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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Metastatic Malignant Solid Neoplasm; Metastatic Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Health Education

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Lima, Ohio, United States, 45801
      • St. Rita's
    • Richmond, Ohio, United States, 23222
      • Saint Francis Medical Center
    • Youngstown, Ohio, United States, 44504
      • Saint Elizabeth Youngstown Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Complete questionnaires; Behavioral: Health Education; Participate in a video intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Daniel G Stover, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Actual): January 27, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Lung Neoplasms; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: OSU-21313; NCI-2021-13900 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA259985 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No