Sun Protection Education for Melanoma Prevention

(STARS Trial)

Overseen By Tammy K Stump, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment 'Sun Protection Education for Melanoma Prevention'?

Educational campaigns and interventions, like the 'Skinsafe' multimedia program, have been shown to improve people's knowledge about melanoma and encourage protective behaviors against sun exposure, which can help prevent skin cancer. ^{1 2 3 4 5}

Is sun protection education safe for humans?

Sun protection education programs, like those evaluated in schools and communities, have been well-received and shown to improve knowledge and behaviors related to skin cancer prevention without any reported safety concerns. ^{2 3 6 7 8}

How does the Sun Protection Education for Melanoma Prevention treatment differ from other treatments for skin cancer prevention?

This treatment is unique because it focuses on educating people about sun safety and skin cancer prevention through presentations and activities, rather than using medications or medical procedures. It aims to change behavior by increasing awareness and knowledge about the risks of sun exposure and the importance of early detection, which is different from traditional treatments that might involve surgery or medication. ^{2 9 10 11 12}

What is the purpose of this trial?

Drawing from prior school-based skin cancer prevention programs, we have adapted intervention materials to target rural high schoolers. Program components (including in-class education) will be co-implemented by the research team and participating school staff, with a focus on sustainability beyond the immediate study period. Interviews and surveys following initial implementation will evaluate both the effectiveness of the program.

Eligibility Criteria

This trial is for rural high school students to learn about preventing skin cancer. It's designed to raise awareness of sun protection and the dangers of tanning.

Inclusion Criteria

I am a high school student in Utah.

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive general education on skin cancer and skin cancer prevention, complete a skin cancer risk self-assessment tool, and create a sun protection action plan during a 90-minute in-class visit.

1 day

1 visit (in-person, may be split into 2 days)

Follow-up

Participants complete a post-intervention survey to evaluate the effectiveness of the program.

1 month

1 visit (virtual)

Treatment Details

Interventions

• Skin cancer prevention educational presentation and activities

Trial Overview The study tests a skin cancer prevention program in schools, which includes educational presentations and activities. The effectiveness will be measured through interviews and surveys after the program.

Participant Groups

Group I: Skin cancer prevention education Experimental Treatment 1 Intervention

Program components of a rural-adapted skin cancer prevention intervention (i.e., education, action planning exercise, risk assessment activity) will be co-implemented by the research team and participating school staff during a single- or double-session, in-class visit lasting up to 90 minutes. Students will be asked to complete surveys at baseline and one month post-intervention.

Skin cancer prevention educational presentation and activities is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Skin Cancer Prevention Education for:

• Skin Cancer Prevention
• Sun Safety Awareness

Approved in Canada as Sun Safety Education for:

• Skin Cancer Prevention
• Tanning Awareness

Approved in European Union as Tanning Awareness Program for:

• Skin Cancer Prevention
• Sun Protection Education

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

A study of non-dermatologist physicians revealed that 71.4% recognized that their patients have a higher risk of skin cancer compared to the general population, indicating awareness of the issue.

Most physicians (71.4%) reported adequate knowledge of sun protection measures and regularly provide advice on practices like using sunscreen and wearing protective clothing, although some gaps in knowledge still exist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicians involved in the care of patients with high risk of skin cancer should be trained regarding sun protection measures: evidence from a cross sectional study. Thomas, M., Rioual, E., Adamski, H., et al.[2015]

The American Academy of Dermatology has provided free skin cancer screenings to over 600,000 Americans and has reached millions with prevention messages, highlighting a significant effort to control melanoma in the U.S.

The chapter emphasizes the need for integrated strategies in prevention, education, and screening to effectively address the rising rates of melanoma incidence and mortality globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Melanoma control in the United States: current status. Koh, HK., Geller, AC.[2019]

The Skinsafe multimedia intervention significantly improved melanoma knowledge among patients, with scores increasing from 3.03 in the control group to 3.71 in the intervention group after 6 months (P < 0.001).

Patients who received the Skinsafe intervention reported more protective skin behaviors and were more likely to check their moles, indicating that the program effectively encouraged proactive skin health practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a multimedia intervention "Skinsafe" on patients' knowledge and protective behaviors. Glazebrook, C., Garrud, P., Avery, A., et al.[2006]

Visual images significantly enhance patients' knowledge and self-efficacy regarding skin self-examination (SSE), leading to increased motivation and accuracy in detecting melanoma.

The systematic review of 25 studies indicates that incorporating visual aids in educational interventions can effectively promote regular and accurate SSE, which is crucial for early skin cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual images for patient skin self-examination and melanoma detection: a systematic review of published studies. McWhirter, JE., Hoffman-Goetz, L.[2018]

A campaign in Switzerland successfully educated nearly 11,000 people about melanoma risk factors and sun protection, leading to early detection opportunities, as 16% of those examined by dermatologists showed signs of precancerous or cancerous conditions.

Men were identified as having a higher risk for melanoma based on factors like skin type, UV exposure, family history, and childhood sunburns, highlighting the need for targeted educational efforts for at-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention campaign against skin cancer. Heinzerling, LM., Dummer, R., Panizzon, RG., et al.[2017]

A skin cancer prevention education program targeting pre-adolescents in Arizona significantly improved children's knowledge and self-reported behaviors regarding sun safety, with results showing a p-value of less than .001.

The program, which included comprehensive curricula on sun safety and skin cancer, was well-received by schools and the community, and efforts are underway to implement it across all middle schools in Arizona.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sunshine and skin cancer: a school-based skin cancer prevention project. Ramstack, JL., White, SE., Hazelkorn, KS., et al.[2007]

Between 1986 and 1996, awareness of the harmful effects of sun exposure increased significantly, with sunscreen use rising from 35% to 53%, indicating a positive shift in sun protection behavior.

Despite increased awareness, risky behaviors such as sunburning rose from 30% to 39%, highlighting the need for targeted interventions to change attitudes towards tanning and improve sun safety practices, especially among high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in sun exposure knowledge, attitudes, and behaviors: 1986 to 1996. Robinson, JK., Rigel, DS., Amonette, RA.[2019]

A skin cancer education program designed by medical students effectively increased awareness among high school students about the risks of sun exposure, particularly for all skin types, with 88% of participants planning to make actionable behavioral changes after the session.

The program successfully adapted to COVID-19 challenges and highlighted the importance of inclusive educational materials in promoting sun-safe behaviors to prevent skin cancer in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating How a School-Based Skin Cancer Prevention Program Can Change Behavior Among North Carolina Highschoolers. Friday, S., Salisbury, K., Snyder, S., et al.[2023]

A study involving college and high-school students revealed that they had limited knowledge about skin cancer, particularly high-school students, but their understanding improved significantly after an educational program.

Despite some decline in knowledge after 2 weeks, students retained significantly more information about skin cancer prevention and recognition compared to their initial knowledge, highlighting the need for ongoing education due to the rising rates of melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief report: an empirically derived educational program for detecting and preventing skin cancer. Katz, RC., Jernigan, S.[2019]

The rising incidence of skin cancers in the U.S. is linked to cumulative sun exposure, with 80% of sun damage occurring before age 18, highlighting the need for early education on sun protection.

Effective sun protection education should start in early childhood, involving both parents and schools, to instill lifelong sun safety habits and ultimately reduce skin cancer rates in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sun protection education in the United States: what we know and what needs to be taught. Wesson, KM., Silverberg, NB.[2021]

Malignant melanoma is increasingly common, with a 7% annual rise in incidence, highlighting the urgent need for effective prevention and detection strategies.

A new public education program targeting schools, pediatricians, nurses, and state agencies aims to educate at-risk populations about melanoma and skin cancer, potentially improving early detection and prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A plan to promote the prevention and early detection of melanoma. Harris, J.[2016]

The Canadian Dermatology Association's Sun Awareness Program effectively raises awareness about the dangers of UV rays and promotes skin cancer prevention through national campaigns and educational materials, reaching more Canadians each year.

Screening events for skin cancer, like those held in Vancouver from 1991 to 1993, successfully attract at-risk individuals, although they face challenges in organization and participation, particularly among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public education projects in skin cancer. Experience of the Canadian Dermatology Association. Rivers, JK., Gallagher, RP.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Physicians involved in the care of patients with high risk of skin cancer should be trained regarding sun protection measures: evidence from a cross sectional study. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

Melanoma control in the United States: current status. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of a multimedia intervention "Skinsafe" on patients' knowledge and protective behaviors. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Visual images for patient skin self-examination and melanoma detection: a systematic review of published studies. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Prevention campaign against skin cancer. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Sunshine and skin cancer: a school-based skin cancer prevention project. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Trends in sun exposure knowledge, attitudes, and behaviors: 1986 to 1996. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Evaluating How a School-Based Skin Cancer Prevention Program Can Change Behavior Among North Carolina Highschoolers. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Brief report: an empirically derived educational program for detecting and preventing skin cancer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Sun protection education in the United States: what we know and what needs to be taught. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A plan to promote the prevention and early detection of melanoma. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Public education projects in skin cancer. Experience of the Canadian Dermatology Association. [2019]