Prevention Booklet for Skin Cancer

Recruiting at 1 trial location

Overseen By Rania Abdulla

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: No risk behaviors, Under 18, others

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

Compensation: Varies

Number of Visits: 6

2900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of information about skin cancer risk can encourage better prevention habits. Participants will receive either personalized prevention materials based on their genetic risk (Precision Prevention Booklet) or standard prevention materials (Standard Prevention Booklet). The researchers aim to determine which type of message more effectively promotes skin cancer prevention actions. Individuals who have sunburned or tanned in the last year and are willing to complete a questionnaire and provide a saliva sample are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance skin cancer prevention strategies.

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 seems focused on skin cancer prevention activities rather than medication use.

What prior data suggests that these prevention booklets are safe?

Research shows that the Precision Prevention Booklet, which uses genetic information to provide personalized skin cancer prevention advice, is well-received. Studies indicate that tailored information based on MC1R genetic risk can improve skin cancer prevention habits. Importantly, no negative effects have been reported from using these materials, suggesting the booklet is safe and harmless.

Similarly, the Standard Prevention Booklet, offering general skin cancer prevention advice, is widely used and considered safe. It promotes sun safety, a proven method to reduce skin cancer risk, and does not raise any safety concerns.

Overall, both booklets aim to encourage safer sun practices without any known risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of personalized prevention strategies for skin cancer. Unlike the standard approach, which uses generic prevention materials, the Precision Prevention Booklet provides tailored advice based on an individual's MC1R genetic risk. This personalized method could lead to more effective prevention by targeting specific risk factors unique to each person. By understanding how genetic information can optimize prevention, this trial may pave the way for more customized and effective skin cancer prevention strategies in the future.

What evidence suggests that this trial's prevention booklets could be effective for skin cancer prevention?

Research has shown that personalized booklets for skin cancer prevention, using MC1R genetic information, can help individuals at higher risk improve their skin care habits. In this trial, participants in the Precision Prevention Intervention arm will receive these personalized materials. Although this genetic information might not alter sun exposure time, it can enhance prevention and early detection practices. This approach is also cost-effective over time. Precision prevention is emerging as a promising method to help individuals care for their skin by offering tailored advice and strategies. Participants in the Standard Prevention arm will receive standard skin cancer prevention materials. ^{1 6 7 8 9}

Who Is on the Research Team?

Peter Kanetsky, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who visit Tampa Family Health Centers, have had sun exposure leading to tanning or sunburn in the past year, and are willing to answer questions and give a saliva sample. It's not for those without recent skin cancer risk behaviors or who can't consent.

Inclusion Criteria

Be able to provide informed consent (written or electronic)

Self-report skin cancer risk behaviors within the past 12 months, including intentional sun exposure (e.g., outdoor or indoor tanning) or unintentional sun exposure leading to sunburn

Be a patient of any race or ethnicity attending one of the six Tampa Family Health Centers

Exclusion Criteria

Do not report any skin cancer risk behaviors (i.e., no tanning or sunburning in the past 12 months)

Are unwilling or unable to complete the baseline assessment or return the saliva kit

Decline to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive personalized or standard skin cancer prevention materials based on their group assignment

6 months

Initial visit for intervention materials distribution

Follow-up

Participants are monitored for changes in tanning behavior, sun protection behaviors, and other outcomes

12 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Precision Prevention Booklet
• Standard Prevention Booklet

Trial Overview The study compares two types of booklets on skin cancer prevention: a standard one versus a precision one tailored to individual risks based on genetics. The goal is to see which booklet better encourages people to protect their skin.

How Is the Trial Designed?

Group I: Precision Prevention Intervention Active Control 1 Intervention

Participants receive personalized skin cancer prevention materials based on MC1R genetic risk.

Group II: Standard Prevention Active Control 1 Intervention

Participants receive standard skin cancer prevention materials.

Group III: Non-Intervention Active Control 1 Intervention

Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9274978/

Assessment of melanoma precision prevention materials ... The purpose was to assess cognitive responses to generic or precision prevention materials incorporating MC1R genetic risk.

2. nature.com nature.com/articles/s41436-021-01292-w

Impact of personal genomic risk information on melanoma ... Personalized genomic risk information did not influence sun exposure patterns but did improve some skin cancer prevention and early detection behaviors.

3. aacrjournals.org aacrjournals.org/cancerrescommun/article/2/1/28/674376/A-Randomized-Clinical-Trial-of-Precision

A Randomized Clinical Trial of Precision Prevention Materials ... Receipt of MC1R precision prevention materials improved some skin cancer prevention behaviors among higher-risk participants and their ...

4. gimjournal.org gimjournal.org/article/S1098-3600(23)00986-3/fulltext

Long-term cost-effectiveness of a melanoma prevention ... Long-term cost-effectiveness of a melanoma prevention program using genomic risk information compared with standard prevention advice in Australia

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8801740/

The Future of Precision Prevention for Advanced Melanoma Precision prevention of advanced melanoma is fast becoming a realistic prospect, with personalized, holistic risk stratification allowing patients to be ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9286490/

A Randomized Clinical Trial of Precision Prevention Materials ... Precision prevention incorporating genetic testing for (melanocortin-1 receptor) MC1R, a skin cancer susceptibility marker, may improve prevention behavior.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07222995

Study Details | NCT07222995 | Hybrid Effectiveness ... Precision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021054344

Impact of personal genomic risk information on melanoma ... Personalized genomic risk information did not influence sun exposure patterns but did improve some skin cancer prevention and early detection behaviors.

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e22613

Promoting sun safety and melanoma prevention in the ... Background: Although among the most preventable cancers, skin cancer is the most common cancer in the United States.