Trial Outcomes & Findings for A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer (NCT NCT05215769)
NCT ID: NCT05215769
Last Updated: 2026-04-13
Results Overview
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.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
243 participants
Primary outcome timeframe
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 posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Cohort 1- Breast
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other Cancer
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
69
|
62
|
57
|
|
Overall Study
Enrolled and initiated T1 survey participation
|
54
|
66
|
60
|
56
|
|
Overall Study
Completed T2 survey participation
|
54
|
64
|
59
|
56
|
|
Overall Study
Completed T3 survey participation
|
50
|
51
|
50
|
52
|
|
Overall Study
COMPLETED
|
50
|
51
|
50
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
18
|
12
|
57
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1- Breast
n=55 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=69 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
n=62 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
n=57 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=193 Participants
|
63 years
n=193 Participants
|
63 years
n=386 Participants
|
66 years
n=112 Participants
|
63 years
n=103 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=193 Participants
|
37 Participants
n=193 Participants
|
24 Participants
n=386 Participants
|
37 Participants
n=112 Participants
|
153 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=193 Participants
|
32 Participants
n=193 Participants
|
38 Participants
n=386 Participants
|
20 Participants
n=112 Participants
|
90 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
White
|
50 Participants
n=193 Participants
|
62 Participants
n=193 Participants
|
55 Participants
n=386 Participants
|
46 Participants
n=112 Participants
|
213 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
9 Participants
n=112 Participants
|
23 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino or Spanish
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
2 Participants
n=112 Participants
|
3 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Other Race or Ethnicity
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
2 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=193 Participants
|
69 participants
n=193 Participants
|
62 participants
n=386 Participants
|
57 participants
n=112 Participants
|
243 participants
n=103 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Number of participants analyzed includes all participants who completed all three time points of the study.
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.
Outcome measures
| Measure |
Cohort 1- Breast
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=51 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
n=52 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Message-specific Knowledge/Recall Accuracy
T1 (Baseline)
|
88.8 Percent of questions answered correctly
Interval 80.0 to 100.0
|
85.53 Percent of questions answered correctly
Interval 80.0 to 100.0
|
88.0 Percent of questions answered correctly
Interval 80.0 to 100.0
|
85.38 Percent of questions answered correctly
Interval 80.0 to 100.0
|
|
Message-specific Knowledge/Recall Accuracy
T2 (After participating in video intervention)
|
96.8 Percent of questions answered correctly
Interval 100.0 to 100.0
|
92.67 Percent of questions answered correctly
Interval 90.0 to 100.0
|
95.0 Percent of questions answered correctly
Interval 90.0 to 100.0
|
91.73 Percent of questions answered correctly
Interval 90.0 to 100.0
|
|
Message-specific Knowledge/Recall Accuracy
T3 (After receiving NGS results)
|
91.4 Percent of questions answered correctly
Interval 90.0 to 100.0
|
89.59 Percent of questions answered correctly
Interval 90.0 to 100.0
|
92.0 Percent of questions answered correctly
Interval 90.0 to 100.0
|
91.15 Percent of questions answered correctly
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed includes all participants who completed all three time points of the study.
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.
Outcome measures
| Measure |
Cohort 1- Breast
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=51 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
n=52 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Patient Genomic Knowledge
T1 (Baseline)
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
80 Percent of questions answered correctly
Interval 70.0 to 90.0
|
|
Patient Genomic Knowledge
T2 (After participating in video intervention)
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
|
Patient Genomic Knowledge
T3 (After receiving NGS results)
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
90 Percent of questions answered correctly
Interval 80.0 to 97.5
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed includes all participants who completed all three time points of the study.
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.
Outcome measures
| Measure |
Cohort 1- Breast
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=51 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
n=52 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Patient Trust of Physician/Provider
T1 (Baseline)
|
50.5 score on a scale
Interval 44.25 to 53.0
|
46.22 score on a scale
Interval 42.13 to 53.88
|
50 score on a scale
Interval 43.25 to 52.0
|
44.5 score on a scale
Interval 39.0 to 52.0
|
|
Patient Trust of Physician/Provider
T2 (After participating in video intervention)
|
51 score on a scale
Interval 45.0 to 54.0
|
48 score on a scale
Interval 40.0 to 52.88
|
50 score on a scale
Interval 45.0 to 53.0
|
45 score on a scale
Interval 41.5 to 52.5
|
|
Patient Trust of Physician/Provider
T3 (After receiving NGS results)
|
50 score on a scale
Interval 47.0 to 53.0
|
50 score on a scale
Interval 45.0 to 53.0
|
49.5 score on a scale
Interval 43.0 to 53.0
|
45 score on a scale
Interval 41.75 to 51.0
|
SECONDARY outcome
Timeframe: 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)Population: Only breast cancer and lung cancer cohorts were analyzed for this outcome measure
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.
Outcome measures
| Measure |
Cohort 1- Breast
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=51 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients
T1 (Baseline)
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
—
|
—
|
|
Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients
T2 (After participating in video intervention)
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
90 Percent of questions answered correctly
Interval 80.0 to 100.0
|
—
|
—
|
|
Change in Patient Genomic Knowledge in Metastatic Breast Cancer (MBC) Versus Metastatic Lung Cancer (MLC) Patients
T3 (After receiving NGS results)
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
90 Percent of questions answered correctly
Interval 80.0 to 90.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Only breast cancer and lung cancer cohorts were analyzed for this outcome measure
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.
Outcome measures
| Measure |
Cohort 1- Breast
n=50 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 2- Lung
n=51 Participants
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 3- Other
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
Cohort 4- Community
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Health Education: Participate in a video intervention
Questionnaire Administration: Complete questionnaires
|
|---|---|---|---|---|
|
Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients
T1 (Baseline)
|
50.5 score on a scale
Interval 44.25 to 53.0
|
46.22 score on a scale
Interval 42.13 to 53.88
|
—
|
—
|
|
Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients
T2 (After participating in video intervention)
|
51 score on a scale
Interval 45.0 to 54.0
|
48 score on a scale
Interval 40.0 to 52.88
|
—
|
—
|
|
Change in Patient Trust of Physician/Provider in MBC Versus MLC Patients
T3 (After receiving NGS results)
|
50 score on a scale
Interval 47.0 to 53.0
|
50 score on a scale
Interval 45.0 to 53.0
|
—
|
—
|
Adverse Events
Health Services Research (Video)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Daniel G. Stover
Ohio State University Comprehensive Cancer Center
Phone: (614) 685-6700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place