- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Jersey
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New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute
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연락하다:
- Anna Mitarotondo, MS
- 전화번호: 732-514-2891
- 이메일: atm122@cinj.rutgers.edu
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연락하다:
- Carolyn J. Heckman, PhD
- 이메일: teenhealthstudy@cinj.rutgers.edu
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수석 연구원:
- Carolyn J. Heckman, PhD
-
수석 연구원:
- Katie A. Devine, PhD, MPH
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Teen MMS & Parent Facebook Intervention
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of recruitment
기간: Baseline
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Feasibility of recruitment will be assessed by the proportion of eligible parent-teen dyads that enroll in the study
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Baseline
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Acceptability of MMS intervention
기간: Immediately after the intervention
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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.
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Immediately after the intervention
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Engagement with MMS intervention
기간: 3-months
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Proportion of messages viewed will be calculated to describe engagement.
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3-months
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Feasibility of Outcome Data Collection - 7-Day Diaries
기간: Baseline, 3-months, 6-months
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Proportion of teens who complete 7-day diaries will be calculated.
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Baseline, 3-months, 6-months
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Feasibility of Outcome Data Collection - UVR Dosimeter
기간: Baseline, 6 months
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Proportion of teens who return UVR dosimeter with usable data will be calculated.
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Baseline, 6 months
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Retention
기간: 3-months, 6-months
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Proportion of enrolled teens who complete surveys at 3- and 6-months will be calculated.
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3-months, 6-months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Carolyn Heckman, PhD, Rutgers, The State University of New Jersey
- 수석 연구원: Katie A Devine, PhD, Rutgers, The State University of New Jersey
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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