Trial Outcomes & Findings for Family Lifestyles, Actions, and Risk Education Intervention: Version 2 (NCT NCT04201223)
NCT ID: NCT04201223
Last Updated: 2026-07-10
Results Overview
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.
COMPLETED
NA
752 participants
Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessment
2026-07-10
Participant Flow
Parent and child participants received a baseline questionnaire after enrolling but prior to randomization. Because of this, the number at the start of the participant flow differs from the enrollment number since only the randomized participants were included in participant flow. In order to be randomized, the parent needed to complete the questionnaire, and those who did not complete it were not randomized. Child completion of questionnaire was not required for randomization.
Participant milestones
| Measure |
FLARE Intervention Parent
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention parent.
|
FLARE Intervention Child
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention child.
|
Standard Education Parent
Participants will be randomized to receive information on child sun protection that is publicly available.
Control parent.
|
Standard Education Child
Participants will be randomized to receive information on child sun protection that is publicly available.
Control child.
|
|---|---|---|---|---|
|
Intervention
STARTED
|
180
|
180
|
184
|
184
|
|
Intervention
Session 1
|
169
|
169
|
167
|
167
|
|
Intervention
Session 2
|
162
|
162
|
163
|
163
|
|
Intervention
Mid-Intervention Assessment
|
157
|
154
|
152
|
147
|
|
Intervention
Session 3
|
160
|
160
|
163
|
163
|
|
Intervention
COMPLETED
|
169
|
169
|
180
|
180
|
|
Intervention
NOT COMPLETED
|
11
|
11
|
4
|
4
|
|
Follow Up
STARTED
|
169
|
169
|
180
|
180
|
|
Follow Up
Post-Intervention Survey 1
|
151
|
144
|
146
|
138
|
|
Follow Up
Post-Intervention Survey 2
|
145
|
136
|
139
|
129
|
|
Follow Up
1 Year Post-Baseline
|
142
|
135
|
140
|
137
|
|
Follow Up
COMPLETED
|
167
|
167
|
177
|
177
|
|
Follow Up
NOT COMPLETED
|
2
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
FLARE Intervention Parent
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention parent.
|
FLARE Intervention Child
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention child.
|
Standard Education Parent
Participants will be randomized to receive information on child sun protection that is publicly available.
Control parent.
|
Standard Education Child
Participants will be randomized to receive information on child sun protection that is publicly available.
Control child.
|
|---|---|---|---|---|
|
Intervention
Withdrawal by Subject
|
11
|
11
|
4
|
4
|
|
Follow Up
Withdrawal by Subject
|
2
|
2
|
3
|
3
|
Baseline Characteristics
Family Lifestyles, Actions, and Risk Education Intervention: Version 2
Baseline characteristics by cohort
| Measure |
FLARE Intervention Parent
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention parent.
|
FLARE Intervention Child
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
Intervention child.
|
Standard Education Parent
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
Control parent.
|
Standard Education Child
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
Control child.
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 6.5 • n=9 Participants
|
13.1 years
STANDARD_DEVIATION 2.6 • n=27 Participants
|
44.8 years
STANDARD_DEVIATION 5.9 • n=267 Participants
|
12.8 years
STANDARD_DEVIATION 2.6 • n=265 Participants
|
29.0 years
STANDARD_DEVIATION 16.8 • n=568 Participants
|
|
Sex/Gender, Customized
Female
|
112 Participants
n=9 Participants
|
90 Participants
n=27 Participants
|
116 Participants
n=267 Participants
|
99 Participants
n=265 Participants
|
417 Participants
n=568 Participants
|
|
Sex/Gender, Customized
Male
|
68 Participants
n=9 Participants
|
90 Participants
n=27 Participants
|
68 Participants
n=267 Participants
|
84 Participants
n=265 Participants
|
310 Participants
n=568 Participants
|
|
Sex/Gender, Customized
Other/Non-binary
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=9 Participants
|
176 Participants
n=27 Participants
|
181 Participants
n=267 Participants
|
176 Participants
n=265 Participants
|
713 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=9 Participants
|
175 Participants
n=27 Participants
|
181 Participants
n=267 Participants
|
172 Participants
n=265 Participants
|
707 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
10 Participants
n=568 Participants
|
|
Region of Enrollment
United States
|
180 participants
n=9 Participants
|
180 participants
n=27 Participants
|
184 participants
n=267 Participants
|
184 participants
n=265 Participants
|
728 participants
n=568 Participants
|
PRIMARY outcome
Timeframe: Baseline Assessment (Wk 0) Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 2 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
We will measure the mean/standard deviation of child sunburn occurrence at all timepoints. "In the past month, how many times did your child have a red OR painful sunburn that lasted a day or more?" Minimum value = 0; Maximum value = 5 or more; Lower scores indicate a better outcome.
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Baseline (Wk 0)
|
0.59 score on a scale
Standard Deviation .851
|
0.63 score on a scale
Standard Deviation 0.932
|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Mid-Intervention Assessment
|
0.42 score on a scale
Standard Deviation 0.611
|
0.56 score on a scale
Standard Deviation 0.837
|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
0.29 score on a scale
Standard Deviation 0.522
|
0.51 score on a scale
Standard Deviation 0.849
|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
0.27 score on a scale
Standard Deviation 0.573
|
0.53 score on a scale
Standard Deviation 0.737
|
|
Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
0.26 score on a scale
Standard Deviation 0.486
|
0.51 score on a scale
Standard Deviation 0.644
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 2 - Baseline 4 - Mid-Intervention Assmt 3 - Post Assmt 1 3 - Post Assmt 2 4 - 1-Year Follow-Up
Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone.
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
1-Year-Follow-Up (Wk 52)
|
2.44 score on a scale
Standard Deviation 1.293
|
2.54 score on a scale
Standard Deviation 1.420
|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Baseline Assessment (Wk 0)
|
2.57 score on a scale
Standard Deviation 1.394
|
2.53 score on a scale
Standard Deviation 1.366
|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Mid-Intervention Assessment (Wk 5-6)
|
2.77 score on a scale
Standard Deviation 1.375
|
2.85 score on a scale
Standard Deviation 1.455
|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Post-Assessment 1 (Wk 8-11)
|
2.81 score on a scale
Standard Deviation 1.364
|
2.74 score on a scale
Standard Deviation 1.408
|
|
Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette
Post Assessment 2 (Wk 12-15)
|
2.83 score on a scale
Standard Deviation 1.329
|
2.95 score on a scale
Standard Deviation 1.421
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of sunscreen application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you use sunscreen with an SPF of 30+?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
2.68 score on a scale
Standard Deviation 1.226
|
2.76 score on a scale
Standard Deviation 1.209
|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
3.79 score on a scale
Standard Deviation 0.850
|
3.28 score on a scale
Standard Deviation 1.105
|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
3.64 score on a scale
Standard Deviation 0.964
|
3.29 score on a scale
Standard Deviation 1.170
|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
3.41 score on a scale
Standard Deviation 1.122
|
2.96 score on a scale
Standard Deviation 1.201
|
|
Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
3.13 score on a scale
Standard Deviation 1.293
|
3.02 score on a scale
Standard Deviation 1.310
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of sunscreen re-application occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you re-apply sunscreen after being outside for 2 hours, in the water, or sweating?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
2.17 score on a scale
Standard Deviation 1.146
|
2.23 score on a scale
Standard Deviation 1.104
|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
3.04 score on a scale
Standard Deviation 1.118
|
2.61 score on a scale
Standard Deviation 1.140
|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
3.01 score on a scale
Standard Deviation 1.138
|
2.62 score on a scale
Standard Deviation 1.115
|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
Post Assessment 2 (Wk 12-15)
|
2.74 score on a scale
Standard Deviation 1.195
|
2.38 score on a scale
Standard Deviation 1.042
|
|
Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey
1-Year-Follow-Up (Wk 52)
|
2.63 score on a scale
Standard Deviation 1.377
|
2.39 score on a scale
Standard Deviation 1.168
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of long sleeved shirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday in the sun for 15 minutes or more. How often did you wear a shirt with long sleeves?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
4.03 score on a scale
Standard Deviation 0.977
|
4.09 score on a scale
Standard Deviation 0.913
|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
4.06 score on a scale
Standard Deviation 0.998
|
3.90 score on a scale
Standard Deviation 0.961
|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
4.04 score on a scale
Standard Deviation 0.940
|
4.01 score on a scale
Standard Deviation 0.906
|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
3.99 score on a scale
Standard Deviation 0.957
|
3.97 score on a scale
Standard Deviation 1.025
|
|
Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
4.29 score on a scale
Standard Deviation 0.872
|
4.11 score on a scale
Standard Deviation 0.957
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of long pants/skirt occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you wear long pants or a long skirt?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
3.00 score on a scale
Standard Deviation 1.233
|
3.16 score on a scale
Standard Deviation 1.199
|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
2.69 score on a scale
Standard Deviation 1.222
|
2.70 score on a scale
Standard Deviation 1.144
|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
2.73 score on a scale
Standard Deviation 1.146
|
2.71 score on a scale
Standard Deviation 1.298
|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
2.86 score on a scale
Standard Deviation 1.205
|
3.00 score on a scale
Standard Deviation 1.279
|
|
Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
3.67 score on a scale
Standard Deviation 1.165
|
3.33 score on a scale
Standard Deviation 1.172
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of shade occurrence at all timepoints. "These next questions ask about what you have done in the past month if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you stay in the shade or under an umbrella?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
2.90 score on a scale
Standard Deviation 0.797
|
2.64 score on a scale
Standard Deviation 0.828
|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
2.32 score on a scale
Standard Deviation 0.868
|
2.46 score on a scale
Standard Deviation 0.934
|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
2.95 score on a scale
Standard Deviation 0.760
|
2.69 score on a scale
Standard Deviation 0.757
|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11)
|
3.03 score on a scale
Standard Deviation 0.831
|
2.67 score on a scale
Standard Deviation 0.734
|
|
Parent Report on Child Shade Use Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
2.87 score on a scale
Standard Deviation 0.909
|
2.54 score on a scale
Standard Deviation 0.873
|
SECONDARY outcome
Timeframe: Baseline Assessment (Wk 0), Mid-Intervention Assessment (Wk 5-6), Post-Assessment 1 (Wk 8-11), Post-Assessment 2 (Wk 12-15), 1-Year Follow-Up (Wk 52), up to 52 weeks from the baseline assessmentPopulation: The number analyzed at each timepoint was determined by the number of participants who completed the questionnaire. Participants were not included in the timepoint if they didn't complete the questionnaire, skipped the question associated with the outcome, or withdrew from the study. More details provided in participant flow. Number of participants who skipped question associated with outcome: 1 - Mid-Intervention Assmt 1 - Post Assmt 1 1. \- Post Assmt 2 2. \- 1-Year Follow-Up
Mean/standard deviation of avoidance of peak hours at all timepoints. "These next questions ask about what you have done in the past (time frame) if you were outdoors on a typical weekend day (Saturday-Sunday) in the sun for 15 minutes or more. How often did you avoid being in the sun between 10:00AM-4:00PM?" Minimum value = 1; Maximum value = 5 on a scale from "Never" to "Always"; Higher scores indicate a better outcome
Outcome measures
| Measure |
FLARE Intervention
n=180 Participants
Participants will be randomized to receive an intervention that works with melanoma survivors and their children as a family unit to improve melanoma preventive behaviors.
FLARE Intervention: \[See arm/group descriptions\]
|
Standard Education
n=184 Participants
Participants will be randomized to receive information on child sun protection that is publicly available.
|
|---|---|---|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Baseline Assessment (Wk 0)
|
2.24 score on a scale
Standard Deviation 0.953
|
2.33 score on a scale
Standard Deviation 0.919
|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Mid-Intervention Assessment (Wk 5-6)
|
2.95 score on a scale
Standard Deviation 0.825
|
2.64 score on a scale
Standard Deviation 0.784
|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Post-Assessment 1 (Wk 8-11
|
2.98 score on a scale
Standard Deviation 0.886
|
2.72 score on a scale
Standard Deviation 0.861
|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
Post-Assessment 2 (Wk 12-15)
|
2.89 score on a scale
Standard Deviation 0.929
|
2.60 score on a scale
Standard Deviation 0.900
|
|
Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey
1-Year Follow-Up (Wk 52)
|
2.89 score on a scale
Standard Deviation 1.018
|
2.49 score on a scale
Standard Deviation 0.882
|
Adverse Events
FLARE Intervention
Standard Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Yelena Wu
Huntsman Cancer Institute at University of Utah
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place