Trial Outcomes & Findings for Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access (NCT NCT04420273)
NCT ID: NCT04420273
Last Updated: 2021-11-23
Results Overview
Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1000 participants
Primary outcome timeframe
90 days
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
SSE Educational Intervention
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Overall Study
STARTED
|
501
|
499
|
|
Overall Study
COMPLETED
|
390
|
414
|
|
Overall Study
NOT COMPLETED
|
111
|
85
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Melanoma Detection With Skin Self-Examination During COVID-19 Restricted Physician Access
Baseline characteristics by cohort
| Measure |
SSE Educational Intervention
n=494 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=495 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
Total
n=989 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
494 Participants
n=99 Participants
|
495 Participants
n=107 Participants
|
989 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
47.0 years
n=99 Participants
|
47.0 years
n=107 Participants
|
47.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=99 Participants
|
495 Participants
n=107 Participants
|
989 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
457 Participants
n=99 Participants
|
459 Participants
n=107 Participants
|
916 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
485 Participants
n=99 Participants
|
480 Participants
n=107 Participants
|
965 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
skin type
I (always sunburn, never tan)
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
skin type
II (usually sunburn, tan minimally)
|
213 Participants
n=99 Participants
|
230 Participants
n=107 Participants
|
443 Participants
n=206 Participants
|
|
skin type
III (sometimes sunburn, tan moderately)
|
216 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
416 Participants
n=206 Participants
|
|
skin type
IV(rarely sunburn, tan deeply)
|
36 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Home sample collection arm participants were randomized into arm 1 at baseline
Self-reported performance of SSE, a custom scale with the frequency and extent of SSE is completed in an online monthly survey
Outcome measures
| Measure |
SSE Educational Intervention
n=494 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=495 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Number of Participants Who Completed SSE at Specified Time Points
baseline ever perform SSE
|
217 Participants
|
242 Participants
|
|
Number of Participants Who Completed SSE at Specified Time Points
3-mo perform SSE
|
348 Participants
|
211 Participants
|
|
Number of Participants Who Completed SSE at Specified Time Points
1-mo perform SSE
|
475 Participants
|
238 Participants
|
|
Number of Participants Who Completed SSE at Specified Time Points
2-mo perform SSE
|
355 Participants
|
228 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: While 494 participants were randomized to receive the intervention, only 278 participants found a concerning mole. Similarly 495 participants were randomized to the active control arm, but only 144 identified a concerning mole. Thus the number analyzed in each arm is limited to the number of participants identifying a concerning mole.
Self-reported identification of concerning mole identified by user assigning scores to the border,color and diameter of the mole. A validated scoring system is used to categorize the border, color and diameter as 1 if normal, 2 if not sure, and 3 if abnormal.The sum of the scores indicates if the mole is concerning (sum of 3= benign, stop checking the mole; sum of 4- 7 monitor the mole for change in the next month; sum of 8-9 = concerning mole make an appointment to see a physician.
Outcome measures
| Measure |
SSE Educational Intervention
n=278 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=144 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Number of Participants Who Identified Concerning Moles at Specified Time Points
Made physician appointment
|
39 Participants
|
107 Participants
|
|
Number of Participants Who Identified Concerning Moles at Specified Time Points
Followed mole for change
|
239 Participants
|
7 Participants
|
|
Number of Participants Who Identified Concerning Moles at Specified Time Points
stopped SSE
|
0 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 90 daysSelf-reported responses to 6 items, each with a 5-point Likert scale (range 6-30) higher score= more anxiety, a worse outcome
Outcome measures
| Measure |
SSE Educational Intervention
n=390 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=414 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Participants' Reported Skin Self-examination Anxiety
Baseline
|
6.4 units on a scale
Standard Deviation 0.05
|
6.4 units on a scale
Standard Deviation 0.05
|
|
Participants' Reported Skin Self-examination Anxiety
Follow-up month 3
|
6.6 units on a scale
Standard Deviation 0.05
|
6.6 units on a scale
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: 90 daysSelf-reported responses to 7 items, each with a 5-point Likert scale (range 7-35) higher score = greater confidence (better outcome).
Outcome measures
| Measure |
SSE Educational Intervention
n=390 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=414 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Participants' Confidence Performing Mole Checks
Baseline
|
9.3 units on a scale
Standard Deviation 0.05
|
9.3 units on a scale
Standard Deviation 0.05
|
|
Participants' Confidence Performing Mole Checks
Follow-up-3 month
|
11.6 units on a scale
Standard Deviation 0.05
|
10.0 units on a scale
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: 5 monthsElectronic medical record review of physician's clinical diagnosis of concerning mole during the 3 months of the study and for 2 subsequent months
Outcome measures
| Measure |
SSE Educational Intervention
n=39 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=107 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
Clinical diagnosis benign
|
14 participants
|
93 participants
|
|
Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
Clinical diagnosis atypical nevus
|
15 participants
|
9 participants
|
|
Clinical Diagnosis of Participants Having Any Physician Visits for Concerning Moles
Clinical diagnosis melanoma
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: all participants in arm 3 had benign moles on the home sample collected
Electronic medical record review of pathologic diagnosis of biopsied moles that participants identified as concerning
Outcome measures
| Measure |
SSE Educational Intervention
n=22 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=14 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Pathologic Diagnosis of Concerning Moles
atypical nevus
|
13 participants
|
6 participants
|
|
Pathologic Diagnosis of Concerning Moles
melanoma stage 0
|
5 participants
|
3 participants
|
|
Pathologic Diagnosis of Concerning Moles
benign nevus
|
0 participants
|
1 participants
|
|
Pathologic Diagnosis of Concerning Moles
melanoma stage 1A
|
4 participants
|
3 participants
|
|
Pathologic Diagnosis of Concerning Moles
melanoma stage 1B
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 5 monthsPopulation: percentage of participants having a biopsy of a concerning mole
EMR review of physician performing a biopsy on a concerning mole identified by the participant, percentage of biopsies performed
Outcome measures
| Measure |
SSE Educational Intervention
n=39 Participants
Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
SSE educational intervention: Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
|
Active Control: Healthy Living
n=107 Participants
Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
Active control:Healthy Living: Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
|
|---|---|---|
|
Biopsy Performed
|
56.4 percentage of participants having a biop
|
13.1 percentage of participants having a biop
|
Adverse Events
SSE Educational Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control: Healthy Living
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. June Robinson
Northwestern University Feinberg School of Medicine
Phone: 3129433703
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place