FLARE Intervention for Melanoma Prevention

(FLARE Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Non-English speakers, Developmental delay, CDKN2A/p16 testing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a program called FLARE can help families adopt better habits to prevent melanoma, a type of skin cancer. It involves melanoma survivors and their children, who will receive either the FLARE intervention (a behavioral program) or standard sun protection education. Each family will participate for just over a year, engaging in live sessions and receiving follow-up reminders. Melanoma survivors with a child aged 8-17 who has had at least one sunburn in the past year may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could benefit families in preventing melanoma.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FLARE intervention is safe for melanoma prevention?

Research has shown that the FLARE program effectively teaches sun protection habits to prevent melanoma, particularly in children with a family history of the disease. As the program centers on education and behavior change, it is considered safe for participants. Studies have not reported any safety issues or negative effects. By focusing on habit changes rather than medications or medical procedures, the program typically involves less risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FLARE Intervention for melanoma prevention because it takes a family-centered approach to instill preventive behaviors against melanoma. Unlike standard education methods that simply provide publicly available information on sun protection, FLARE actively involves melanoma survivors and their children, focusing on improving habits as a family unit. This collaborative approach aims to create lasting behavioral changes by leveraging family dynamics and support systems, which could lead to more effective prevention of melanoma than traditional educational methods.

What evidence suggests that the FLARE intervention is effective for improving melanoma preventive behaviors?

Research has shown that the FLARE program, which participants in this trial may receive, aims to improve habits that help prevent melanoma, especially in families where a parent has survived melanoma. Studies suggest that teaching children how to protect themselves from the sun can lower their risk of sunburn, which is linked to developing melanoma. The program includes personalized sessions with parents and children to encourage these protective habits. By focusing on family education, the FLARE program seeks to reduce the chances of melanoma in at-risk children. Early results are promising, indicating that such programs can effectively teach better sun safety habits. Participants in another arm of this trial will receive standard education on child sun protection that is publicly available. ^{1 2 4 5 6}

Who Is on the Research Team?

Yelena Wu, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for melanoma survivors aged 18+ and their children aged 8-17. Eligible adults must have a history of melanoma and at least one child who can join the study with them. Children qualify if they've had a sunburn in the past year. Families cannot join if they've been tested for CDKN2A/p16 mutations, don't speak English, or have developmental delays.

Inclusion Criteria

I am over 18, have had melanoma, and have a child aged 8-17 who can join the trial with me.

My child is 8-17, had a sunburn last year, and I have a history of melanoma.

Exclusion Criteria

I do not have a developmental delay that prevents participation.

I have not been tested for the CDKN2A/p16 mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Parent-child dyads participate in three bi-weekly live intervention sessions with an interventionist

6 weeks

3 visits (virtual)

Post-Intervention Assessment

Participants complete post-intervention assessments to evaluate changes in sunburn occurrence and preventive behaviors

8 weeks

Follow-up

Participants are monitored for long-term changes in sunburn occurrence and preventive behaviors

1 year

What Are the Treatments Tested in This Trial?

Interventions

• FLARE Intervention

Trial Overview The FLARE intervention aims to improve melanoma preventive behaviors among parent-child pairs where the parent is a melanoma survivor. Participants are randomly placed into two groups: one receives FLARE education while the other gets standard advice, followed by bi-weekly sessions and quarterly reminders over a year.

How Is the Trial Designed?

Group I: FLARE Intervention Experimental Treatment 1 Intervention

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.

Group II: Standard Education Active Control 1 Intervention

Participants will be randomized to receive information on child sun protection that is publicly available.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529923/

The Family Lifestyles, Actions and Risk Education (FLARE ... This study will test the efficacy of the FLARE intervention and examine moderators and mediators of its effects. The primary goals of the study are to 1) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37393004/

Protocol for a randomized controlled trial of a sun protection ... The FLARE trial addresses the need for melanoma preventive interventions for children with familial risk for the disease.

3. withpower.com withpower.com/trial/flare-intervention-for-melanoma-prevention-92275

FLARE Intervention for Melanoma Prevention (FLARE Trial) Trial Overview The FLARE intervention aims to improve melanoma preventive behaviors among parent-child pairs where the parent is a melanoma survivor.

4. stacks.cdc.gov stacks.cdc.gov/view/cdc/148848

The Family Lifestyles, Actions and Risk Education (FLARE) ... If efficacious, FLARE could help to mitigate familial risk for melanoma among these children by teaching practices which, if enacted, decrease sunburn ...

5. bohrium.com bohrium.com/paper-details/the-family-lifestyles-actions-and-risk-education-flare-study-protocol-for-a-randomized-controlled-trial-of-a-sun-protection-intervention-for-children-of-melanoma-survivors/882472000780501152-7334

The family lifestyles, actions and risk education (FLARE) ... The study uses repeated measures and structural equation modeling to analyze the data. The primary goals are to evaluate the efficacy of the FLARE intervention ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423001994

The Family Lifestyles, Actions and Risk Education (FLARE) ... FLARE is a theoretically-guided intervention aimed at promoting child sun protection and decreasing sunburn occurrence by enhancing perceived risk of melanoma.