Melanoma Risk Assessment & Tailored Intervention (PennSCAPE)
Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
연구 개요
상세 설명
This study aims to evaluate the impact of a mailed, tailored intervention, on the skin cancer prevention and skin self-examination behaviors of high-risk and moderate-risk adults. Participants will be recruited in primary health care setting (Penn Radnor Clinic) after their scheduled appointment. During Phase I of this study, patients will be screened for their level of risk for skin cancer. They will be asked to complete a survey as well as undergo a quick skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II of the study, and will then complete a baseline survey either in person, over the phone, or via mail after they have consented. After completing a baseline survey, these participants will be randomized to receive tailored materials, including personalized risk feedback, or to a control group that will receive generic educational materials. Participants will then be re-assessed at follow-up approximately three (3) months later via a mailed survey.
The intervention consists of one to three sets of intervention materials, depending on if they are randomized to the generic group or the tailored group. The first mailing will be sent out approximately two weeks after a participant completes the baseline survey, and is designed to educate participants on ways to prevent skin cancer though personalized behavioral changes. The second mailing will be sent out two weeks after the first mailing, and is designed to provide a guide to participants on steps to complete a skin self exam. Finally, the third mailing will be sent out two weeks after the second mailing, and will provide medical information to the participants regarding types of skin cancer along with tips to remember that encompass information from previous mailings.
Finally, the participant will complete a follow-up survey approximately one (1) month after the last mailing has been mailed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
To be included in Phase I, a subject must meet all of the following criteria:
- Subjects are capable of giving informed consent
- Subjects are ≥ 18 years old.
- Subjects are English speaking and can read English
To be included for analysis during Phase II, a subject must meet all of the following criteria:
- Subjects must meet all criteria listed in Phase I.
- Subjects are identified as Caucasian.
- Subjects must be at moderate or high risk for skin cancer, based on scores from the BRAT and Fears combined risk assessment.
Exclusion Criteria:
- Children under the age of 18 will not be included.
- For Phase II, previously diagnosed with melanoma.
- For Phase II, planning to be away for three (3) consecutive weeks or longer in June, July, or August
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 대조군
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Phase I: Patients are screened for their level of risk for skin cancer. They will complete a survey and undergo a skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II. Phase II: Three sets of materials will be sent in the mail over the course of 6 weeks. Pamphlets will contain information about ways to reduce participant's risk of skin cancer, including sun protection practices, benefits of skin screening practices, and how to do skin self-examinations. The participant will also complete two surveys for this study, one at baseline and then one at follow up approximately three months later. Each survey will ask the participant about:
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다른: Tailored Intervention
We will mail three separate pamphlets created specifically for the participant.
The information in the pamphlets will be based on answers from the first survey.
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Phase I: Patients are screened for their level of risk for skin cancer. They will complete a survey and undergo a skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II. Phase II: Three sets of materials will be sent in the mail over the course of 6 weeks. Pamphlets will contain information about ways to reduce participant's risk of skin cancer, including sun protection practices, benefits of skin screening practices, and how to do skin self-examinations. The participant will also complete two surveys for this study, one at baseline and then one at follow up approximately three months later. Each survey will ask the participant about:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Compare the effects of offering tailored print materials to that of generic print materials on perceived risk of melanoma, sun avoidance/protection, and skin self-examination behaviors.
기간: 3-6 months total per participant
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In Phase II of this study, we will conduct a randomized trial to compare the effects of a tailored intervention to a standard intervention of brochures with risk communication, skin cancer prevention, and skin cancer detection information.
Outcomes are sun protection, sun exposure, frequency of sunburns, and skin examinations.
Subjects in Phase II will be adults at moderate and high risk for skin cancer based on the scores they received from the risk assessment in Phase I.
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3-6 months total per participant
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen Glanz, PhD, MPH, University of Pennsylvania
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PennSCAPE
- 5UC2CA148310-02 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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