- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Cancer Institute
-
Contact:
- Anna Mitarotondo, MS
- Phone Number: 732-514-2891
- Email: atm122@cinj.rutgers.edu
-
Contact:
- Carolyn J. Heckman, PhD
- Email: teenhealthstudy@cinj.rutgers.edu
-
Principal Investigator:
- Carolyn J. Heckman, PhD
-
Principal Investigator:
- Katie A. Devine, PhD, MPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of recruitment
Time Frame: Baseline
|
Feasibility of recruitment will be assessed by the proportion of eligible parent-teen dyads that enroll in the study
|
Baseline
|
|
Acceptability of MMS intervention
Time Frame: 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
|
|
Engagement with MMS intervention
Time Frame: 3-months
|
Proportion of messages viewed will be calculated to describe engagement.
|
3-months
|
|
Feasibility of Outcome Data Collection - 7-Day Diaries
Time Frame: 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
Time Frame: Baseline, 6 months
|
Proportion of teens who return UVR dosimeter with usable data will be calculated.
|
Baseline, 6 months
|
|
Retention
Time Frame: 3-months, 6-months
|
Proportion of enrolled teens who complete surveys at 3- and 6-months will be calculated.
|
3-months, 6-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carolyn Heckman, PhD, Rutgers, The State University of New Jersey
- Principal Investigator: Katie A Devine, PhD, Rutgers, The State University of New Jersey
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro2025001264
- R34CA293237 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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