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

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05215769
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 225
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 32.9
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: Health Education; Other: Questionnaire Administration	N/A

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 225 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
• Actual Study Start Date: Apr 6, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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.	Behavioral: Health Education; Participate in a video intervention; Other: Questionnaire Administration; Complete questionnaires

Outcome Measures

Primary Outcome Measures

1. Message-specific knowledge/recall accuracy [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.

Secondary Outcome Measures

1. Change in patient genomic knowledge [Immediately before and immediately after video intervention]

   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.

2. Change in patient trust of physician/provider [Immediately before and immediately after video intervention]

   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.

3. Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients [Immediately before and immediately after video intervention]

   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.

4. Change in patient trust of physician/provider in MBC versus MLC patients [Immediately before and immediately after video intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Daniel G Stover, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Jamesline

Publications

None provided.

• Responsible Party: Daniel Stover, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT05215769
• Other Study ID Numbers: OSU-21313; NCI-2021-13900; R21CA259985
• First Posted: Jan 31, 2022
• Last Update Posted: Apr 25, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Breast Neoplasms; Lung Neoplasms

Study Results

No Results Posted as of Apr 25, 2022