Skin CancerNCT07222995
Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in FQHCs
A study testing Precision Prevention Booklet and Standard Prevention Booklet in people with Skin Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to examine how different messages about risk of skin cancer can impact the uptake of skin cancer prevention activities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Precision Prevention Booklet and Standard Prevention Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,900 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2025to 10 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be a patient of any race or ethnicity attending one of the six Tampa Family Health Centers.
- Be 18 years of age or older.
- 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 willing to complete a baseline questionnaire and provide a saliva sample for MC1R genotyping.
- Be able to provide informed consent (written or electronic).
- Prefer English or Spanish for communication and study materials.
Who cannot join
- 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.
- Are under 18 years of age.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Peter Kanetsky, PhD, MPH
Margaret Byrne, PhD
About this study
Official title: A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers
The purpose of this study is to examine how different messages about risk of skin cancer can impact the uptake of skin cancer prevention activities.
- Conditions
- Skin Cancer
- Being tested
- Precision Prevention Booklet, Standard Prevention Booklet
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Prevention BookletBehavioural
Precision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk representations and simple language.
Standard Prevention BookletBehavioural
Standard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk.
| Study group | Role | What they receive |
|---|---|---|
| Precision Prevention Intervention | Active comparator | Participants receive personalized skin cancer prevention materials based on MC1R genetic risk. Receives: Behavioral: Precision Prevention Booklet |
| Standard Prevention | Active comparator | Participants receive standard skin cancer prevention materials. Receives: Behavioral: Standard Prevention Booklet |
| Non-Intervention | No intervention | Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tanning Score
Change in self-reported tanning behavior score from baseline to 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Number of Sunburns
Change in self-reported number of sunburns experienced over the past 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Skin self-examination (SSE)
Change in self-reported SSE from baseline to 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Physician-patient communication about skin cancer prevention.
Change in self-reported physician-patient communication from baseline to 6 and 12 months.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (3)
Change in Hours Spent Outside in the Sun
Change in self-reported average weekly hours spent outdoors in direct sunlight, assessed via questionnaire.
Measured: Baseline, 6 months, 12 months
Change in Sun Protection Behaviors
Change in frequency of sun protection behaviors, including use of sunscreen, wearing protective clothing, and seeking shade, assessed via a composite behavior scale.
Measured: Baseline, 6 months, 12 months
Receipt of Total Body Skin Examination (TBSE)
Proportion of participants who report referral for and receiving a total body skin examination by a healthcare professional during the study period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start10 Oct 2025
- Primary completion10 Oct 2030 (estimated)
- Study completion10 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Peter Kanetsky, PhD, MPH, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222995
- Sponsor's protocol ID
- MCC-23436
- Status last verified
- Feb 2026
- First submitted
- 28 Oct 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sutton SK, Turner K, Chung-Bridges K, Vadaparampil ST, Abdulla R, Arevalo M, Avrilien N, Byrne MM, Endemano E, Hernandez JG, Hamilton JG, Lyjak E, Parrales Z, Ramos J, Torres M, White B, Hay JL, Kanetsky PA. A hybrid effectiveness-implementation trial to integrate precision skin cancer risk feedback in federally qualified health centers. Contemp Clin Trials. 2026 Aug 14:108439. doi: 10.1016/j.cct.2026.108439. Online ahead of print.
PubMed 42600921
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Effectiveness-Implementation Trial to Integrate Precision Skin Cancer Risk Feedback in Federal Qualified Health Centers
- ClinicalTrials.gov ID
- NCT07222995
- Acronym / sponsor ID
- MCC-23436
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,900 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 10 Oct 2030 (estimated)
- Study completion
- 10 Oct 2030 (estimated)
- First posted
- 31 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine how different messages about risk of skin cancer can impact the uptake of skin cancer prevention activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Precision Prevention Intervention | Active comparator | Behavioral: Precision Prevention BookletParticipants receive personalized skin cancer prevention materials based on MC1R genetic risk. |
| Standard Prevention | Active comparator | Behavioral: Standard Prevention BookletParticipants receive standard skin cancer prevention materials. |
| Non-Intervention | No intervention | –Participants who do not return saliva kits will not receive intervention materials but will complete follow-up assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be a patient of any race or ethnicity attending one of the six Tampa Family Health Centers.
- Be 18 years of age or older.
- 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 willing to complete a baseline questionnaire and provide a saliva sample for MC1R genotyping.
- Be able to provide informed consent (written or electronic).
Key exclusion criteria (4 listed)
- 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.
- Are under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision Prevention BookletPrecision prevention booklet anchored in their MC1R risk that incorporates gold-standard risk communication strategies, including visual risk representations and simple language. | Behavioural | Precision Prevention Intervention |
| Standard Prevention BookletStandard materials are similar in content to the precision prevention booklet but without any reference to MC1R risk. | Behavioural | Standard Prevention |
Primary outcome
Change in Tanning Score
Time frame: Baseline, 6 months, 12 months
Change in self-reported tanning behavior score from baseline to 6 and 12 months.
Number of Sunburns
Time frame: Baseline, 6 months, 12 months
Change in self-reported number of sunburns experienced over the past 6 and 12 months.
Skin self-examination (SSE)
Time frame: Baseline, 6 months, 12 months
Change in self-reported SSE from baseline to 6 and 12 months.
Physician-patient communication about skin cancer prevention.
Time frame: Baseline, 6 months, 12 months
Change in self-reported physician-patient communication from baseline to 6 and 12 months.
3 secondary outcomes
Change in Hours Spent Outside in the Sun
Time frame: Baseline, 6 months, 12 months
Change in Sun Protection Behaviors
Time frame: Baseline, 6 months, 12 months
Receipt of Total Body Skin Examination (TBSE)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 42600921Sutton SK, Turner K, Chung-Bridges K, Vadaparampil ST, Abdulla R, Arevalo M, Avrilien N, Byrne MM, Endemano E, Hernandez JG, Hamilton JG, Lyjak E, Parrales Z, Ramos J, Torres M, White B, Hay JL, Kanetsky PA. A hybrid effectiveness-implementation trial to integrate precision skin cancer risk feedback in federally qualified health centers. Contemp Clin Trials. 2026 Aug 14:108439. doi: 10.1016/j.cct.2026.108439. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Kanetsky, PhD, MPH principal investigator
Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Prevention Booklet and Standard Prevention Booklet in people with Skin Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania Abdulla (813-745-6813, Rania.Abdulla@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tanning Score (time frame: Baseline, 6 months, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07222995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.