Melanoma Risk Assessment & Tailored Intervention

Melanoma Clinical Trial

— PennSCAPE  

Official title:

Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356771
• Other study ID #: PennSCAPE
• Secondary ID: 5UC2CA148310-02
• Status: Completed
• Phase: N/A
• First received: April 29, 2011
• Last updated: August 17, 2016
• Start date: May 2011
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators are conducting a study to provide evidence about the comparative effectiveness of mailed, tailored intervention materials on cancer prevention behavioral outcomes. The investigators will send out three (3) tailored mailings for participants who are assigned to the intervention group. Second, during the eligibility screening, the investigators will be assessing the relative yield and functioning of two risk assessment tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be included in Phase I, a subject must meet all of the following criteria:

1. Subjects are capable of giving informed consent

2. Subjects are = 18 years old.

3. 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:

1. Subjects must meet all criteria listed in Phase I.

2. Subjects are identified as Caucasian.

3. Subjects must be at moderate or high risk for skin cancer, based on scores from the BRAT and Fears combined risk assessment.

Exclusion Criteria:

1. Children under the age of 18 will not be included.

2. For Phase II, previously diagnosed with melanoma.

3. For Phase II, planning to be away for three (3) consecutive weeks or longer in June, July, or August

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Melanoma
• Skin Cancer
• Skin Neoplasms

Intervention

Other:
• Surveys & Mailed Materials
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: Current and past skin cancer screening practices Current and past sun protection practices Attitudes about skin cancer and sun protection Knowledge of melanoma

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3-6 months total per participant	No