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

NCT05215769 | Active Not Recruiting Results DMC

• 3 other identifiers: OSU-21313NCI-2021-13900R21CA259985
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Study Arms (1)

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.

Behavioral: Health Education; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Complete questionnaires

Health services research (video)

Health Education BEHAVIORAL

Participate in a video intervention

Health services research (video)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have biopsy-confirmed metastatic cancer
• Be \>= 18 years of age
• Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS

You may not qualify if:

• Exclude patients who are not English- or Spanish-speaking

Sponsors & Collaborators

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

Study Sites (4)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

St. Rita's

Lima, Ohio, 45801, United States

Location

Saint Francis Medical Center

Richmond, Ohio, 23222, United States

Location

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44504, United States

Location

Related Publications (1)

• 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.

  PMID: 38106014 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Daniel G. Stover
• Organization: Ohio State University Comprehensive Cancer Center

Daniel.Stover@osumc.edu

(614) 685-6700

Study Officials

• Daniel G Stover, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: March 30, 2022
• Primary Completion: January 27, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)