Melanoma Risk Assessment & Tailored Intervention (PennSCAPE)
Primary Purpose
Melanoma, Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surveys & Mailed Materials
Sponsored by
About this trial
This is an interventional supportive care trial for Melanoma focused on measuring Risk Assessment, Intervention
Eligibility Criteria
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control Group
Tailored Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01356771
First Posted
April 29, 2011
Last Updated
August 17, 2016
Sponsor
University of Pennsylvania
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01356771
Brief Title
Melanoma Risk Assessment & Tailored Intervention
Acronym
PennSCAPE
Official Title
Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Skin Cancer
Keywords
Risk Assessment, Intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
323 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Title
Tailored Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Surveys & Mailed Materials
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3-6 months total per participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Glanz, PhD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Melanoma Risk Assessment & Tailored Intervention
We'll reach out to this number within 24 hrs