Trial Outcomes & Findings for Streamlined Genetic Testing in Prostate Cancer (NCT NCT04359758)
NCT ID: NCT04359758
Last Updated: 2024-01-17
Results Overview
Receipt of genetic testing results as indicated in clinic records
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Three Months Post-Randomization
Results posted on
2024-01-17
Participant Flow
Potentially eligible participants were identified via the electronic health record at Medstar Georgetown University Hospital. The first participant was enrolled in February 2020 and the last participant was enrolled in March 2021.
Of 216 potentially eligible participants, 112 completed the baseline survey and were randomized. Five participants were found to be ineligible after randomization (i.e., protocol violation). Thus, the final sample was comprised of 107 men who were randomized to ST (n=53) vs UC (n=54).
Participant milestones
| Measure |
Proactive Streamlined Genetic Education and Testing
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
56
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Proactive Streamlined Genetic Education and Testing
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
Baseline Characteristics
Streamlined Genetic Testing in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Proactive Streamlined Genetic Education and Testing
n=53 Participants
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
n=54 Participants
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Education
College Degree
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Education
Less Than College Degree
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Marital Status
Married/Partnered
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Marital Status
Not Married/Partnered
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three Months Post-RandomizationPopulation: Intent to Treat (all participants assigned to ST or UC).
Receipt of genetic testing results as indicated in clinic records
Outcome measures
| Measure |
Proactive Streamlined Genetic Education and Testing
n=53 Participants
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
n=54 Participants
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Number of Participants Completing Genetic Testing
Completed Genetic Testing
|
22 Participants
|
15 Participants
|
|
Number of Participants Completing Genetic Testing
Declined Genetic Testing
|
31 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 3 Months Post RandomizationPopulation: Participants completing the 3-month follow-up assessment. Three participants who completed the 3-month follow-up failed to complete this scale. Thus, the final sample size for this analysis was N=103.
Satisfaction with Decision Scale Higher values indicate greater satisfaction with the genetic testing decision. Range = 6 to 30.
Outcome measures
| Measure |
Proactive Streamlined Genetic Education and Testing
n=52 Participants
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
n=51 Participants
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Decision Satisfaction
|
21.3 score on a scale
Standard Deviation 6.6
|
23.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 3 Months Post RandomizationDecision Regret Scale Higher score indicates greater regret regarding the genetic testing decision Range = 0 to 100
Outcome measures
| Measure |
Proactive Streamlined Genetic Education and Testing
n=53 Participants
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
n=51 Participants
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Decisional Regret
|
26.5 score on a scale
Standard Deviation 21.4
|
25.4 score on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 3 Months Post RandomizationPopulation: Total number of randomized participants who completed the PROMIS depression and anxiety measures
Patient Reported Outcomes Measurement Information System - Depression Short Scale 6A T-Scores (Mean = 50 and SD = 10; Range = 38.4 to 80.3) Higher scores indicate greater depression Patient Reported Outcomes Measurement Information System - Anxiety Short Scale 6A T-Scores (Mean = 50, SD = 10; Range = 39.1 to 82.7) Higher scores indicate more anxiety
Outcome measures
| Measure |
Proactive Streamlined Genetic Education and Testing
n=52 Participants
Participants randomized to this arm will proactively receive genetic education print materials and the option to proceed directly with genetic testing.
Proactive Streamlined Genetic Education and Testing: This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
|
Usual Care
n=52 Participants
Participants in this arm will be sent a referral letter recommending that they schedule a genetic counseling session and providing them with contact information to do so.
Usual Care: This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
|
|---|---|---|
|
Distress
Anxiety - Baseline
|
48.5 T-Score
Standard Deviation 8.5
|
48.4 T-Score
Standard Deviation 9.1
|
|
Distress
Anxiety - 3-Months
|
47.5 T-Score
Standard Deviation 9.2
|
47.4 T-Score
Standard Deviation 8.8
|
|
Distress
Depression - Baseline
|
43.6 T-Score
Standard Deviation 6.8
|
47.4 T-Score
Standard Deviation 8.7
|
|
Distress
Depression - 3-Months
|
44.0 T-Score
Standard Deviation 7.8
|
45.9 T-Score
Standard Deviation 8.6
|
Adverse Events
Proactive Streamlined Genetic Education and Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Marc D. Schwartz, PhD
Georgetown Lombardi Comprehensive Cancer center
Phone: 2026870185
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place