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

NCT ID: NCT05215769

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Health Education

Intervention Type BEHAVIORAL

Participate in a video intervention

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Health Education

Participate in a video intervention

Intervention Type BEHAVIORAL

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Stover

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel G Stover, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

St. Rita's

Lima, Ohio, United States

Site Status

Saint Francis Medical Center

Richmond, Ohio, United States

Site Status

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38106014 (View on PubMed)

Related Links

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Other Identifiers

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NCI-2021-13900

Identifier Type: REGISTRY

Identifier Source: secondary_id

R21CA259985

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-21313

Identifier Type: -

Identifier Source: org_study_id

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