N/A
Completed N=42
Family Lifestyle Actions and Risk Education Study
Melanoma · Child
Source: ClinicalTrials.gov NCT02846714 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist — 36 Participants
Summary
The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist |
36 | — |
| SECONDARY Photoprotective Behaviors Assessed With the Sun Habits Survey |
4.29; 3.56; 2.29; 2.76; 2.71; 3.38 | — |
| SECONDARY Photoprotective Behaviors Assessed With the PALE Questionnaire |
17.00; 27.10; 11.03; 20.66; 6.74; 18.47 | — |
| SECONDARY Skin Self-exam Occurrence Assessed Via Questionnaire |
8; 6; 2; 4; 8; 8 | — |
| SECONDARY Skin Self-exam Occurrence Assessed Via Diary |
6; 3; 3; 4; 5; 7 | — |
| SECONDARY Sunburn Occurrence Assessed Via Diary |
0; 4; 2; 1; 2; 4 | — |
| SECONDARY Sunburn Occurrence Assessed Via Questionnaire |
7; 0; 5; 2; 1; 1 | — |
| SECONDARY Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device |
-1.38; .110 | — |
| SECONDARY Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire |
17.00; 27.10; 11.03; 20.66; 6.74; 18.47 | — |
| SECONDARY Degree of Tan on Skin Assessed Via Reflectance Spectroscopy |
.59; .49; .77; .71; .57; .56 | — |
| SECONDARY Photoprotection Behavior Changes Assessed Via Questionnaire |
-.61; .06; -.27; -.08; .50; .56 | — |
| SECONDARY Skin Self-exam Behavior Changes |
.25; 0; 3.65; -1.06; -.31; .27 | — |
| SECONDARY Acceptability of Intervention Assessed Via Questionnaire |
51.67; 49.36 | — |
Eligibility Criteria
Inclusion Criteria
Children
- Are 8-17 years old AND
- Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR
- Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
Adults
- Are at least 18 years old AND
- Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND
- Have at least one child under age 18 who is living in the same household AND
- Have a personal history of melanoma and/or family history of melanoma) AND/OR
- Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing
Exclusion Criteria
- Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English
Data sourced from ClinicalTrials.gov (NCT02846714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.