- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07681791
Sun Safe Together: A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Melanoma is a leading cause of invasive cancer in teens and young adults aged 15-39. Most skin cancers are preventable with skin protection such as minimizing UVR exposure and wearing protective clothing and sunscreen. However, teens have low levels of sun protection. Thus, interventions targeting skin cancer risk reduction among teens are needed. The proposed Sun Safe Together (SST) intervention is a 12-week program consisting of sun safety and general health messages sent via multimedia messaging service (MMS) to teens and via a private Facebook group for parents.
This pilot trial is a single arm test of SST to determine:
- feasibility of enrolling parent-teen dyads
- engagement with/acceptability of the intervention via message views and acceptability ratings
- outcome data collection feasibility (i.e., daily diary, UVR exposure measured by UVR dosimeter)
- retention rates for teens and parents at 3 and 6 months
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
New Brunswick, New Jersey, Forente stater, 08901
- Rekruttering
- Rutgers Cancer Institute
-
Ta kontakt med:
- Anna Mitarotondo, MS
- Telefonnummer: 732-514-2891
- E-post: atm122@cinj.rutgers.edu
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Ta kontakt med:
- Carolyn J. Heckman, PhD
- E-post: teenhealthstudy@cinj.rutgers.edu
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Hovedetterforsker:
- Carolyn J. Heckman, PhD
-
Hovedetterforsker:
- Katie A. Devine, PhD, MPH
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Parents and teens are participating as dyads, meaning both the parent and the teen need to be deemed eligible based on the criteria below to be able to participate.
Teens
- Must be ages 13-17 years
- Live with study parent equal to or greater than half time in US
- Have experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have access to smartphone
- Speak and read English
Parents/Guardians
- Must be age 18 or older
- Live with a teen equal to or greater than half time in US
- Have a teen who had experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have internet at home, a Facebook account, and be willing to use Facebook daily
- Have access to smartphone
- Speak and read English
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Teen MMS & Parent Facebook Intervention
|
Teens will receive MMS messages regarding sun safety behaviors and other general health issues for 12 weeks.
Parents of teenagers join a private Facebook group where membership, activities, and content are only viewable by invited members.
Content related to teen sun safety and general health will be posted for 12 weeks.
Research staff will moderate the group.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of recruitment
Tidsramme: Baseline
|
Feasibility of recruitment will be assessed by the proportion of eligible parent-teen dyads that enroll in the study
|
Baseline
|
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Acceptability of MMS intervention
Tidsramme: Immediately after the intervention
|
Items were adapted from the Acceptability of Intervention and Feasibility of Intervention Measures to obtain participant feedback about the acceptability, feasibility, ease of use, and impact of the intervention.
Individual items are rated on a 5-point likert scale from (1) Completely Disagree to (5) Completely Agree.
Higher scores indicated greater acceptability.
|
Immediately after the intervention
|
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Engagement with MMS intervention
Tidsramme: 3-months
|
Proportion of messages viewed will be calculated to describe engagement.
|
3-months
|
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Feasibility of Outcome Data Collection - 7-Day Diaries
Tidsramme: Baseline, 3-months, 6-months
|
Proportion of teens who complete 7-day diaries will be calculated.
|
Baseline, 3-months, 6-months
|
|
Feasibility of Outcome Data Collection - UVR Dosimeter
Tidsramme: Baseline, 6 months
|
Proportion of teens who return UVR dosimeter with usable data will be calculated.
|
Baseline, 6 months
|
|
Retention
Tidsramme: 3-months, 6-months
|
Proportion of enrolled teens who complete surveys at 3- and 6-months will be calculated.
|
3-months, 6-months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Carolyn Heckman, PhD, Rutgers, The State University of New Jersey
- Hovedetterforsker: Katie A Devine, PhD, Rutgers, The State University of New Jersey
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Pro2025001264
- R34CA293237 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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