Trial Outcomes & Findings for Skin Health Online for Melanoma: Better Risk Assessment (NCT NCT03130569)
NCT ID: NCT03130569
Last Updated: 2024-12-05
Results Overview
Reach is defined as registration of a personalized genomic testing for melanoma (PGT-M) test decision, either for or against testing (dichotomous outcome; test decision or no test decision). Additional assessments of reach include baseline survey completion and decision to pursue PGT-M testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
600 participants
Primary outcome timeframe
Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
Control Group
Will simply complete surveys at baseline and at the three-month follow-up.
|
Web-based Module Group
Participants will complete surveys at baseline. Participants in this arm will be provided with information to access and complete a web-based educational module (AKA the intervention), at the end of which will be given the opportunity to request and complete genetic testing for skin cancer. Participants who elect to complete the genetic testing will receive their genetic testing results along with a two-week follow-up call. All participants will also complete the survey at the three month follow-up.
Web-based Module Group
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
499
|
|
Overall Study
COMPLETED
|
82
|
401
|
|
Overall Study
NOT COMPLETED
|
19
|
98
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skin Health Online for Melanoma: Better Risk Assessment
Baseline characteristics by cohort
| Measure |
Control Group
n=101 Participants
Will simply complete surveys at baseline and at the three-month follow-up.
|
Web-based Module Group
n=499 Participants
Participants will complete surveys at baseline. Participants in this arm will be provided with information to access and complete a web-based educational module (AKA the intervention), at the end of which will be given the opportunity to request and complete genetic testing for skin cancer. Participants who elect to complete the genetic testing will receive their genetic testing results along with a two-week follow-up call. All participants will also complete the survey at the three month follow-up.
Web-based Module Group
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
77 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
454 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
23 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Age, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
396 Participants
n=7 Participants
|
473 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian / Alaska Native
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 Participants
n=5 Participants
|
356 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other race
|
20 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
499 participants
n=7 Participants
|
600 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three months from enrollment for each participant. Enrollment occurs on a rolling basis, to be completed August 2017.Population: Data for this outcome was not collected for the control group.
Reach is defined as registration of a personalized genomic testing for melanoma (PGT-M) test decision, either for or against testing (dichotomous outcome; test decision or no test decision). Additional assessments of reach include baseline survey completion and decision to pursue PGT-M testing.
Outcome measures
| Measure |
Control Group
Group that received no intervention
|
Web-Based Module Group
n=499 Participants
Group that completed the web-based modules and were offered the opportunity to test.
|
|---|---|---|
|
Reach of Personalized Genomic Testing for Melanoma.
Registered a Test Decision For Testing
|
0 Participants
|
204 Participants
|
|
Reach of Personalized Genomic Testing for Melanoma.
Registered a Test Decision Against Testing
|
0 Participants
|
295 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Web-based Module Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Hay
Memorial Sloan Kettering Cancer Center
Phone: 646-888-0039
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place