Melanoma Risk Assessment & Tailored Intervention

NCT ID: NCT01356771

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Conditions

Melanoma; Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Group Type: OTHER

Surveys & Mailed Materials

Intervention Type: OTHER

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

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.

Group Type: OTHER

Surveys & Mailed Materials

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Glanz, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

5UC2CA148310-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PennSCAPE

Identifier Type: -

Identifier Source: org_study_id