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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
- ClinicalTrials.gov ID
- NCT05215769
- Acronym / sponsor ID
- OSU-21313
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (video) | Experimental | Behavioral: Health Education, Other: Questionnaire AdministrationPatients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have biopsy-confirmed metastatic cancer
- Be >= 18 years of age
- Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS
Key exclusion criteria (1 listed)
- Exclude patients who are not English- or Spanish-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationParticipate in a video intervention | Behavioural | Health services research (video) |
| Questionnaire AdministrationComplete questionnaires | Other | Health services research (video) |
Primary outcome
Message-specific Knowledge/Recall Accuracy
Time frame: 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)
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.
4 secondary outcomes
Patient Genomic Knowledge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42868120Veney 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.
- Derived from this study: PubMed 38106014Veney 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel G Stover, MD principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Message-specific Knowledge/Recall Accuracy (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215769, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.