Child, Melanoma
Conditions
Keywords
Education, Prevention and Control, Behavioral Research
Brief summary
The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.
Detailed description
Enrollment After parent-child dyads complete screening and informed consent/assent procedures, participants will be invited to complete an online baseline assessment. Following the baseline assessment, dyads will be randomized to receive either the FLARE intervention or standard education. After randomization, each dyad will receive a unique log-in to a secure study website that will be used to review didactic materials prior to each intervention session. Intervention Sessions Dyads will meet with an interventionist via remotely-delivered live session for their three intervention sessions. Intervention sessions will be scheduled every two weeks. After completion of the last remotely-delivered session, all parents will receive quarterly booster messages via text or email. Study Assessments Dyads will be asked to complete online assessments after consent is given (baseline) and within the 4 days prior to Session 3. A first post-intervention assessment will occur 4 weeks after the last intervention session is held. A second post-intervention assessment will occur 4 weeks later. The long-term follow-up assessment will take place 1-year post-baseline. Each assessment is expected to take 15-30 minutes. Parents will also receive a brief assessment via text or email (depending on parent preference) at monthly intervals between the second post-assessment and the 1-year post-baseline assessment, and in the summer months immediately following the 1-year post-baseline assessment. All assessments will be completed electronically.
Interventions
BEHAVIORALFLARE Intervention
\[See arm/group descriptions\]
Sponsors
University of Utah
American Cancer Society, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 110 Years
Healthy volunteers
Yes
Inclusion criteria
Adults are eligible for this trial if they: * Are at least 18 years old AND * Have been diagnosed with melanoma at any time in their life AND * Have at least one biological child between the ages of 8-17 years who is able to participate in the trial with them. Children are eligible to participate with their parent if they: * Are between the ages of 8-17 years AND * Had at least 1 sunburn in the last 12 months AND * Have at least one biological parent with a history of melanoma who can participate in the trial with them.
Exclusion criteria
Adults and children will be excluded from participation if they meet any of the following: * Do not speak English * Are unable to participate due to developmental delay * Received testing for a mutation in CDKN2A/p16, including those who participated in a previous study where they received information on CDKN2A/p16. * Enrolled in a study led by an investigator at another institution, which also focuses on improving skin cancer prevention behaviors and utilizes the Utah Cancer Registry for study recruitment. * Have only a history of ocular melanoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent Report on Child Sunburn Occurrence Assessed Via Sun Habits Survey | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent Report on Child Skin Tone Assessed Via 11-Point Skin Color Palette | 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 | Mean/Standard deviation of skin tone at all timepoints. Minimum value = 1; Maximum value = 11; Higher score indicates darker skin tone. |
| Parent Report on Child Sunscreen Application Assessed Via Sun Habits Survey | 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 | 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 |
| Parent Report on Child Sunscreen Re-Application Assessed Via Sun Habits Survey | 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 | 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 |
| Parent Report on Long Sleeved Shirt Use Assessed Via Sun Habits Survey | 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 | 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 |
| Parent Report on Child Long Pants/Skirt Use Assessed Via Sun Habits Survey | 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 | 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 |
| Parent Report on Child Shade Use Assessed Via Sun Habits Survey | 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 | 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 |
| Parent Report on Child Peak Hours Avoidance Assessed Via Sun Habits Survey | 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 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYelena Wu, PhD
University of Utah
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.0 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 707 Participants |
| Region of Enrollment United States | 728 participants |
| Sex/Gender, Customized Female | 112 Participants |
| Sex/Gender, Customized Male | 68 Participants |
| Sex/Gender, Customized Other/Non-binary | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed