Anatomic Stage IV Breast Cancer AJCC v8NCT05215769
A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
A study testing Health Education and Questionnaire Administration in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma
- What is being tested?
- Health Education and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Mar 2022to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have biopsy-confirmed metastatic cancer
- Be >= 18 years of age
- Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS
Who cannot join
- Exclude patients who are not English- or Spanish-speaking
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
St. Rita's
Lima, Ohio, 45801
Saint Francis Medical Center
Richmond, Ohio, 23222
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44504
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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
- 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
- Being tested
- Health Education, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Participate in a video intervention
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Education; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start30 Mar 2022
- Primary completion27 Jan 2025
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel Stover, Ohio State University Comprehensive Cancer Center
- Investigators
- Daniel G Stover, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215769
- Sponsor's protocol ID
- OSU-21313
- Other IDs
- NCI-2021-13900, R21CA259985
- Status last verified
- Oct 2026
- First submitted
- 18 Jan 2022
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veney DJ, Wei L, Miller J, Toland AE, Presley CJ, Hampel H, Padamsee TJ, Bishop MJ, Kim JJ, Hovick SR, Irvin WJ, Senter L, Stover DG. Application of a concise video to improve patient understanding of tumor genomic testing in community and academic practice settings. PLoS One. 2026 Oct 13;21(10):e0360611. doi: 10.1371/journal.pone.0360611. eCollection 2026.
PubMed 42868120Veney 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.
PubMed 38106014