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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

359 participants

Primary outcome timeframe

Up to 4 weeks after testing

Results posted on

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

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

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

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 testing

Population: 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

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 result

Population: 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

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 results

Population: 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

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 results

Population: 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

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 results

Population: 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

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 testing

Population: 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

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 testing

Population: 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

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
8.7 score on a scale
Standard Deviation 11.5
5.7 score on a scale
Standard Deviation 8.9
4.3 score on a scale
Standard Deviation 6.4
2.3 score on a scale
Standard Deviation 4.0

Adverse Events

Year 1: Without Video - Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Year 2: With Video - Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Year 1: Without Video - Probands

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Year 2: With Video - Proband

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

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

Phone: 2153006428

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place