Trial Outcomes & Findings for HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics (NCT NCT04905082)
NCT ID: NCT04905082
Last Updated: 2025-12-11
Results Overview
Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results.
ACTIVE_NOT_RECRUITING
NA
465 participants
Up to 3 months
2025-12-11
Participant Flow
Participant milestones
| Measure |
Arm I (Usual Care)
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
|
Arm II (Genomics Test Results, HOPE-Genomics)
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
|
Arm III (HOPE-Genomics, Genomics Test Results)
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
155
|
155
|
|
Overall Study
Pre-test Survey (Approximately 2-3 Days After Baseline)
|
140
|
143
|
142
|
|
Overall Study
Ten-day Visit
|
132
|
134
|
129
|
|
Overall Study
Three-month Survey
|
121
|
122
|
122
|
|
Overall Study
COMPLETED
|
104
|
109
|
105
|
|
Overall Study
NOT COMPLETED
|
51
|
46
|
50
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HOPE-Genomics Intervention for the Improvement of Cancer Patient Knowledge of Genomics
Baseline characteristics by cohort
| Measure |
Arm I (Usual Care)
n=155 Participants
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
|
Arm II (Genomics Test Results, HOPE-Genomics)
n=155 Participants
Patients receive their genomics test results both from their clinician and from the HOPE-Genomics tool. Patients then view HOPE-Genomics tool over 15-20 minutes after their results are available.
|
Arm III (HOPE-Genomics, Genomics Test Results)
n=155 Participants
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
0 Participants
n=639 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=237 Participants
|
110 Participants
n=243 Participants
|
116 Participants
n=480 Participants
|
338 Participants
n=639 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=237 Participants
|
45 Participants
n=243 Participants
|
39 Participants
n=480 Participants
|
127 Participants
n=639 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
3 Participants
n=480 Participants
|
5 Participants
n=639 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=237 Participants
|
16 Participants
n=243 Participants
|
19 Participants
n=480 Participants
|
56 Participants
n=639 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
6 Participants
n=480 Participants
|
17 Participants
n=639 Participants
|
|
Race (NIH/OMB)
White
|
114 Participants
n=237 Participants
|
126 Participants
n=243 Participants
|
117 Participants
n=480 Participants
|
357 Participants
n=639 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=237 Participants
|
5 Participants
n=243 Participants
|
6 Participants
n=480 Participants
|
22 Participants
n=639 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
8 Participants
n=639 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=237 Participants
|
37 Participants
n=243 Participants
|
36 Participants
n=480 Participants
|
115 Participants
n=639 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=237 Participants
|
116 Participants
n=243 Participants
|
118 Participants
n=480 Participants
|
344 Participants
n=639 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
6 Participants
n=639 Participants
|
|
Age, Continuous
|
59 Year
n=237 Participants
|
61 Year
n=243 Participants
|
64 Year
n=480 Participants
|
61 Year
n=639 Participants
|
|
Education
Grades 1 through 8
|
0 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
1 Participants
n=639 Participants
|
|
Education
Grades 9 through 11
|
4 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
6 Participants
n=639 Participants
|
|
Education
Grade 12 or GED
|
11 Participants
n=237 Participants
|
10 Participants
n=243 Participants
|
19 Participants
n=480 Participants
|
40 Participants
n=639 Participants
|
|
Education
College 1 Year to 3 Years (Some College or Technical School)
|
43 Participants
n=237 Participants
|
45 Participants
n=243 Participants
|
43 Participants
n=480 Participants
|
131 Participants
n=639 Participants
|
|
Education
College 4 years or More (College Graduate)
|
45 Participants
n=237 Participants
|
48 Participants
n=243 Participants
|
44 Participants
n=480 Participants
|
137 Participants
n=639 Participants
|
|
Education
Master's Degree
|
25 Participants
n=237 Participants
|
29 Participants
n=243 Participants
|
25 Participants
n=480 Participants
|
79 Participants
n=639 Participants
|
|
Education
Doctoral Degree
|
13 Participants
n=237 Participants
|
14 Participants
n=243 Participants
|
18 Participants
n=480 Participants
|
45 Participants
n=639 Participants
|
|
Education
Unknown or Not Reported
|
14 Participants
n=237 Participants
|
8 Participants
n=243 Participants
|
4 Participants
n=480 Participants
|
26 Participants
n=639 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: For the primary analysis, only patients who responded to the question regarding completion of germline testing in either the 10-day or 3-month survey were included. Therefore, the number of patients analyzed differs from the total number of randomized participants.
Recall rate refers to the proportion of patients who accurately remembered whether they had undergone genetic testing, as reported in the 10-day follow-up survey. If a patient's response at the 10-day mark was unavailable, their answer from the 3-month survey was used as a substitute. This metric helps assess how well patients retained and understood information about their genetic testing experience shortly after receiving their results.
Outcome measures
| Measure |
Arm I (Usual Care)
n=132 Participants
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
|
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)
n=137 Participants
This group pools together Arm II and Arm III patients who have access to genomics test results from the HOPE-Genomics tool.
|
Arm III (HOPE-Genomics, Genomics Test Results)
n=131 Participants
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
|
|---|---|---|---|
|
Recall Rates of Personal Genomic Results
Recalled Germline Testing
|
89 Participants
|
82 Participants
|
83 Participants
|
|
Recall Rates of Personal Genomic Results
Not Recalled Germline Testing
|
43 Participants
|
55 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 12-month period after results disclosureIn the primary analysis, we will assess the uptake of contextualized guideline-concordant care taking into account clinically relevant, patient specific circumstances. Will use clinical characteristics from the electronic health record (EHR) to assign each patient to clinical category for which there are discrete National Comprehensive Cancer Network (NCCN) recommendations. Using patient self-reported baseline/T1 and EHR data, following sequencing disclosure, we will create a summary genetically-guided care variable ranging from 0-100%. In the secondary analyses, will define guideline concordant as meeting \>= 75% of recommended guidelines.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 days, 3 months, 9 monthsPopulation: Only participants who answered distress-related questions were included in the analysis.
The psychosocial impact of genetic testing and patient uncertainty were assessed at 10 days, 3 months and 9 months using both the adapted PAGIS Certainty Scale and the FACToR. The FACToR was a 12-item measure that included four subscales: privacy concerns, uncertainty, test-related distress, and positive experiences. The overall FACToR score is computed by summing all items after reverse scoring the positivity subscale, resulting in a total range of 0 to 48. Higher total scores indicate greater psychosocial impact, which is considered a worse outcome. The PAGIS Certainty Subscale consists of 6 items scored on a 1-6 scale, with a total range of 6-36. Higher scores reflect greater certainty and better psychological adaptation to genetic information, which is considered a positive outcome.
Outcome measures
| Measure |
Arm I (Usual Care)
n=121 Participants
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
|
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)
n=126 Participants
This group pools together Arm II and Arm III patients who have access to genomics test results from the HOPE-Genomics tool.
|
Arm III (HOPE-Genomics, Genomics Test Results)
n=120 Participants
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
|
|---|---|---|---|
|
Test-related Distress
FACToR Score at 10-Day
|
11.07 scores on a scale
Standard Deviation 6.29
|
12.37 scores on a scale
Standard Deviation 6.82
|
11.17 scores on a scale
Standard Deviation 7.93
|
|
Test-related Distress
FACToR Score at 3-Month
|
12.32 scores on a scale
Standard Deviation 6.83
|
13.20 scores on a scale
Standard Deviation 7.41
|
12.48 scores on a scale
Standard Deviation 7.47
|
|
Test-related Distress
PAGIS Score at 10 Days
|
24.76 scores on a scale
Standard Deviation 6.74
|
24.25 scores on a scale
Standard Deviation 7.11
|
26.53 scores on a scale
Standard Deviation 6.95
|
|
Test-related Distress
PAGIS Score at 3 Months
|
25.11 scores on a scale
Standard Deviation 7.38
|
24.54 scores on a scale
Standard Deviation 7.23
|
26.11 scores on a scale
Standard Deviation 7.30
|
|
Test-related Distress
PAGIS Score at 9 Months
|
22.29 scores on a scale
Standard Deviation 7.12
|
23.11 scores on a scale
Standard Deviation 7.42
|
24.39 scores on a scale
Standard Deviation 8.34
|
|
Test-related Distress
FACToR Score at 9-Month
|
12.61 scores on a scale
Standard Deviation 7.11
|
11.97 scores on a scale
Standard Deviation 6.31
|
12.19 scores on a scale
Standard Deviation 7.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 9 monthsIn exploratory analyses related to Aim 2 (i.e. receipt of contextual guideline-concordant care), will also operationalize the secondary outcome in an additional way: Categories of genetically-guided care: Will evaluate patients' receipt of 1) treatment recommended by provider based on sequencing (any/none), 2) patients' sharing of sequencing results with family members (any/none), and 3) patients' consultation with genetic counseling/ recommended specialist (any/none).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 9 monthsWill analyze the web-log of user visits (e.g., number of viewing sessions, page views and use of interactive elements).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, pre-test (approximately 2-3 days after baseline), 10 days and 3 monthsPopulation: Only participants who answered at least half of the knowledge questions for corresponding surveys were included in the analysis.
Genomic knowledge was assessed using a modified 35-item instrument comprising three subscales: cancer genomics knowledge, understanding of the use of genetic testing results in cancer care, and germline sequencing knowledge. Overall knowledge scores were calculated for patients who completed more than half of the items in the full measure. Each score was expressed as the percentage of correct responses out of the total number of questions answered in that category, with scores ranging from 0 to 100. The change in pre/post scores was calculated by taking the differences in knowledge scores from baseline to pre-test, 10-days and 3 months survey.
Outcome measures
| Measure |
Arm I (Usual Care)
n=139 Participants
Patients receive education pamphlet about WES and have their genomics test results returned by their clinician in a typical manner.
|
Arm II (Genomics Test Results, HOPE-Genomics) Plus Arm III (HOPE-Genomics, Genomics Test Results)
n=140 Participants
This group pools together Arm II and Arm III patients who have access to genomics test results from the HOPE-Genomics tool.
|
Arm III (HOPE-Genomics, Genomics Test Results)
n=139 Participants
Patients view HOPE-Genomics tool (containing educational content) over 15-20 minutes before their sequencing results are available. Patients also receive their genomics test results both from their clinician and from the HOPE-Genomics tool.
|
|---|---|---|---|
|
Change in Genomic Knowledge Score
Change from baseline to pre-test (approximately 2-3 days after baseline)
|
2.76 Point
Standard Error 14.19
|
1.67 Point
Standard Error 13.36
|
7.39 Point
Standard Error 13.88
|
|
Change in Genomic Knowledge Score
Change from baseline to 10 days
|
1.24 Point
Standard Error 16.92
|
4.86 Point
Standard Error 16.85
|
7.44 Point
Standard Error 16.95
|
|
Change in Genomic Knowledge Score
Change from baseline to 3 months
|
1.63 Point
Standard Error 17.48
|
3.12 Point
Standard Error 18.59
|
6.04 Point
Standard Error 16.32
|
Adverse Events
Arm I (Usual Care)
Arm II (Genomics Test Results, HOPE-Genomics)
Arm III (HOPE-Genomics, Genomics Test Results)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place