Trial Outcomes & Findings for Educational Video for Genetic Testing (NCT NCT05472714)
NCT ID: NCT05472714
Last Updated: 2026-06-16
Results Overview
The primary outcome is the percentage of correct items on a genetic knowledge survey that was developed for this study, measured at baseline and before receipt of genetic test results. Participants evaluated included the primary caregivers, secondary caregivers and probands aged 12+. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.
COMPLETED
NA
359 participants
Up to 4 weeks after testing
2026-06-16
Participant Flow
Patients were identified via existing Cancer Center informatics systems and the Division of Genomic Diagnostics as undergoing paired tumor/normal sequencing. Patients were recruited at least one week after cancer diagnosis and no more than 4 weeks after tumor/normal testing is sent. Families were then approached by phone or in clinic to confirm study eligibility and (if appropriate) obtain informed study consent.
Participants enrolled in year 1 were assigned to the control group (without video). Participants enrolled in year 2 were assigned to the intervention group (with video). Participants enrolled include AYA probands aged 12+ and their caregiver(s).
Participant milestones
| Measure |
Year 1: Without Video - Caregivers
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 2: With Video - Caregivers
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Probands
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
137
|
180
|
18
|
24
|
|
Overall Study
COMPLETED
|
118
|
160
|
14
|
21
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
4
|
3
|
Reasons for withdrawal
| Measure |
Year 1: Without Video - Caregivers
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 2: With Video - Caregivers
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Probands
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
1
|
1
|
|
Overall Study
Physician Decision
|
3
|
2
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
12
|
0
|
1
|
|
Overall Study
Became Ineligible
|
1
|
2
|
2
|
0
|
Baseline Characteristics
N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
Baseline characteristics by cohort
| Measure |
Year 1: Without Video - Caregivers
n=137 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 2: With Video - Caregivers
n=180 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=18 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Probands
n=24 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.52 Years (1 d.p.)
STANDARD_DEVIATION 8.06 • n=20 Participants
|
41.16 Years (1 d.p.)
STANDARD_DEVIATION 8.58 • n=20 Participants
|
17.13 Years (1 d.p.)
STANDARD_DEVIATION 3.28 • n=40 Participants
|
17.62 Years (1 d.p.)
STANDARD_DEVIATION 3.55 • n=6 Participants
|
38.11 Years (1 d.p.)
STANDARD_DEVIATION 10.98 • n=7 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=20 Participants
|
110 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
219 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=20 Participants
|
70 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
13 Participants
n=6 Participants
|
140 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
94 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
124 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
13 Participants
n=40 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
14 Participants
n=6 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
245 Participants
n=7 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
11 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
17 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
3 Participants
n=40 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
2 Participants
n=6 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
33 Participants
n=7 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
|
Race/Ethnicity, Customized
Race · Asian
|
6 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
15 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
1 Participants
n=40 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
2 Participants
n=6 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
24 Participants
n=7 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
|
Race/Ethnicity, Customized
Race · Other/More than one Race
|
9 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
8 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
1 Participants
n=40 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
6 Participants
n=6 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
24 Participants
n=7 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
|
Race/Ethnicity, Customized
Race · Missing
|
17 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
16 Participants
n=20 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
0 Participants
n=40 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
0 Participants
n=6 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
33 Participants
n=7 Participants • N=29 Caregiver participants did not complete measures indicating self-reported race and was not obtainable via EHR, or indicated they did not want to report their race/ethnicity
|
PRIMARY outcome
Timeframe: Up to 4 weeks after testingPopulation: Genetic knowledge scores and percentages were generated if participants completed the full measure. N=65 Incomplete Caregiver surveys were due to: * N=1 Ineligible * N=49 Missed the Timepoint * N= 12 Participants withdrew * N= 3 Were withdrawn by a provider N= 5 Incomplete Proband surveys were due to: * N= 2 Ineligible * N =2 Missed timepoint * N =1 Passively withdrawn by study staff
The primary outcome is the percentage of correct items on a genetic knowledge survey that was developed for this study, measured at baseline and before receipt of genetic test results. Participants evaluated included the primary caregivers, secondary caregivers and probands aged 12+. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=106 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
n=146 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=15 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
n=22 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Percentage of Correct Items on Knowledge Questionnaire - Before Results
|
48.45 Percentage correct (%)
Standard Deviation 26.32
|
62.21 Percentage correct (%)
Standard Deviation 30.04
|
44.44 Percentage correct (%)
Standard Deviation 21.44
|
60.61 Percentage correct (%)
Standard Deviation 31.40
|
SECONDARY outcome
Timeframe: Up to 6 months post-genetic test resultPopulation: Genetic knowledge scores and percentages were generated if participants completed the full measure. In cases where answers were incomplete or missed, scores were omitted. N=46 Incomplete Caregiver surveys: * N=4 Ineligible * N=2 Missed measure * N= 13 Participant withdrew * N= 5 Withdrawn by a provider * N= 22 Lost to follow up N=8 Incomplete proband surveys: * N= 1 Lost to follow up * N= 3 Ineligible * N= 1 Withdrawn by provider * N=1 Missed measure * N = 2 participant withdrew
A secondary analysis includes data from all caregivers' (primary and secondary) and probands' (over 12 years of age) of percentage of correct items on a genetic knowledge survey that was developed for this study, repeated at a second timepoint (T2) after receipt of genetic test results. The knowledge score is a 12-point true/false questionnaire. Total scores were generated by summarizing total number of correct responses and generating a percentage. The Genetic Knowledge measure included 12 true/false questions. Higher scores indicate higher genetic knowledge.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=114 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
n=157 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=14 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
n=20 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Percentage of Correct Items on Knowledge Questionnaire - After Results
|
57.13 Percentage Correct (%)
Standard Deviation 24.04
|
75.18 Percentage Correct (%)
Standard Deviation 27.64
|
51.79 Percentage Correct (%)
Standard Deviation 24.43
|
72.92 Percentage Correct (%)
Standard Deviation 23.40
|
SECONDARY outcome
Timeframe: One time, within 6 months after receipt of resultsPopulation: Incomplete caregiver (CG) surveys ranged N=40-44; AYA ranged N=7-8. Incomplete scores across ALL subscales: Caregivers (N=31): Provider W/D N=5, Became ineligible (BI) N=4, Lost to follow up (LTFU) N=22. AYA (N=7): Participant withdrew (PWD) N=2, Provider W/D, N=1, BI N=3, LTFU N=1. Individual subscales incomplete: SDS: CG N=9 (N=1 missed, N=8 PWD); AYA N=1 (missed) IES Intrusion: CG N=12 (N=3 missed, N=9 PWD) IES Avoidance: CG N=9 (PWD) MICRA: CG N=13 (N=4 missed, N=9 PWD)
Acceptability in all participants (primary caregivers, secondary caregivers and probands aged 12+) will be assessed using a questionnaire including the following measures: * Satisfaction with Decision Scale (SDS): 6-question decision satisfaction measure, scored on Likert scale from 1= strongly disagree to 5= strongly agree. Scores range from 0-30, higher scores indicate greater satisfaction. * Impact of Events Scale for cancer-specific distress (IES): 15-item questionnaire, scored on a Likert scale from 1 (Not at all)- 5 (Often). Total scores range from 0-75, higher scores indicate greater distress. Scores for intrusion subscale range from 0 to 35. The scores for the avoidance subscale range from 0 to 40. * Multidimensional Impact of Cancer Risk Assessment (MICRA) Distress Subscale is a 6-item questionnaire, scored on a Likert scale ranging from 0 (Never) to 5 (Often). Scores range from 0-30, higher scores indicate greater distress. Only sub/scales completed entirely were analyzed.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=114 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
n=160 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=14 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
n=21 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis
Satisfaction with Decision Scale (SDS)
|
26.3 Total score
Standard Deviation 4.7
|
25.7 Total score
Standard Deviation 4.2
|
28.0 Total score
Standard Deviation 2.4
|
24.8 Total score
Standard Deviation 5.3
|
|
Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis
Impact of Events Scale Total (IES) Total
|
8.31 Total score
Standard Deviation 11.26
|
6.25 Total score
Standard Deviation 9.25
|
4.0 Total score
Standard Deviation 8.93
|
4.38 Total score
Standard Deviation 7.37
|
|
Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis
Impact of Events Scale (IES) - Avoidance subscale
|
4.6 Total score
Standard Deviation 6.5
|
3.7 Total score
Standard Deviation 5.4
|
3.2 Total score
Standard Deviation 7.3
|
2.8 Total score
Standard Deviation 4.9
|
|
Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis
Impact of Events Scale (IES) Intrusion subscale
|
3.2 Total score
Standard Deviation 5.6
|
2.7 Total score
Standard Deviation 4.9
|
0.8 Total score
Standard Deviation 1.9
|
1.3 Total score
Standard Deviation 2.8
|
|
Acceptability of Use of an Informational Video on Paired Tumor/Normal Testing for Participants With a New Cancer or Other Diagnosis
Multidimensional Impact of Cancer Risk Assessment (MICRA) - Distress Subscale
|
4.8 Total score
Standard Deviation 6.0
|
5.2 Total score
Standard Deviation 6.9
|
1.6 Total score
Standard Deviation 3.4
|
3.2 Total score
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: One time, within 6 months after receipt of resultsPopulation: 204 (N=121 primary caregivers, N=59 secondary caregivers, N= 24 probands) made up 124 family units that were assigned to the intervention arm. Since the intervention arm were the only participants to receive the video intervention, only the Year 2: video received sample were evaluated assessed for intervention feasibility.
Feasibility will be assessed with absence of mean number of technical difficulties of video delivery reported by research staff from date of receiving genetic testing.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=124 Family unit
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Intervention Feasibility - Technical Error
|
0 Mean technical errors
Standard Deviation 0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One time, within 6 months after receipt of resultsPopulation: 204 (N=121 primary caregivers, N=59 secondary caregivers, N= 24 probands) made up 124 family units participants were assigned to the intervention arm. Since the intervention arm were the only participants to receive the video intervention, only the Year 2: video received sample were evaluated assessed for intervention feasibility.
Feasibility will be assessed by timeliness of delivery of video after recommendation for testing, defined in average number of days to receive intervention from date of receiving genetic testing.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=124 Families
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Intervention Feasibility - Days to Receive Intervention
|
14.9 Days
Standard Deviation 8.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks after testingPopulation: SDS Incomplete N=62 * Caregiver N=57 (Missed N=31, Participant withdrew N=7, Provider withdrew N=3, Became ineligible N=1, Lost to follow up N=15). * AYA N=5 (Missed N=2, Provider withdrew N=1, Became ineligible N=2)
Satisfaction with Decision Scale (SDS): a 6-question decision satisfaction measure, scored on a Likert scale from 1= strongly disagree to 5= strongly agree. Higher total scores indicate greater satisfaction with decisions for pursuing genetic testing. Scores range from 0-30, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=107 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
n=149 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=15 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
n=22 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Satisfaction With Decision Scale (SDS) - Before Results
|
26.6 score on a scale
Standard Deviation 3.9
|
26.1 score on a scale
Standard Deviation 3.8
|
25.7 score on a scale
Standard Deviation 6.0
|
25.2 score on a scale
Standard Deviation 4.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks after testingPopulation: Total incomplete subscales ranged N=63-65. Across All IES scores and subscales incomplete surveys included: * CG N=27 (Participant withdrew N=8, Provider withdrew N=3, Became ineligible N=1, Lost to follow up N=15). * AYA N=3 (Provider withdrew N=1, Became ineligible N=2) Incomplete IES Total Ns: * CG N=32 (missing) * AYA N=3 (missing) Incomplete IES avoidance Ns: * CG N=31 (missing) * AYA N=2 (missing) Incomplete IES intrusion Ns: * CG N=31 (missing) * AYA N=3 (missing)
This 15-item measure assesses cancer-related anxiety through two subscales (intrusive thinking and avoidance). Responses are measured on a 4-point Likert scale with the following anchors: 0 "not at all", 1 "rarely", 3 "sometimes", and 5 "often". Scores range from 0 to 35 for intrusion, 0 to 40 for avoidance, and 0 to 75 for the total IES. Higher scores indicate greater cancer-related anxiety.
Outcome measures
| Measure |
Year 1: Without Video - Caregivers
n=106 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included caregivers probands receiving genetic testing.
|
Year 2: With Video - Caregivers
n=150 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included caregivers of probands receiving genetic testing consented to participate.
|
Year 1: Without Video - Probands
n=15 Participants
In year 1, investigators will recruit families of patients receiving the current standard-of-care approach to tumor-normal genetic testing with provider-based education. Participants enrolled in this group included probands aged 12+ that consented/assented to participate.
|
Year 2: With Video - Proband
n=22 Participants
In year 2, investigators will recruit families of patients receiving the updated standard-of-care approach to tumor-normal genetic testing with provider-based education and an educational video. Participants enrolled in this group included Probands aged 12+ that consented/assented to participate.
|
|---|---|---|---|---|
|
Impact of Events Scale (IES) - Before Results
IES Avoidance Subscale
|
4.7 score on a scale
Standard Deviation 6.3
|
3.1 score on a scale
Standard Deviation 4.9
|
3.1 score on a scale
Standard Deviation 4.2
|
1.6 score on a scale
Standard Deviation 3.0
|
|
Impact of Events Scale (IES) - Before Results
IES Intrusion Subscale
|
3.9 score on a scale
Standard Deviation 6.0
|
2.6 score on a scale
Standard Deviation 4.6
|
1.2 score on a scale
Standard Deviation 2.6
|
1.1 score on a scale
Standard Deviation 2.1
|
|
Impact of Events Scale (IES) - Before Results
IES Total Score
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8.7 score on a scale
Standard Deviation 11.5
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5.7 score on a scale
Standard Deviation 8.9
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4.3 score on a scale
Standard Deviation 6.4
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2.3 score on a scale
Standard Deviation 4.0
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Adverse Events
Year 1: Without Video - Caregivers
Year 2: With Video - Caregivers
Year 1: Without Video - Probands
Year 2: With Video - Proband
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Suzanne MacFarland MD
Children's Hospital of Philadelphia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place