Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
18 Years
N/A
Both
Melanoma, Skin Cancer
Trial Information
Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
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.
Outcome 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.
Outcome Time Frame:
3-6 months total per participant
Safety Issue:
No
Principal Investigator
Karen Glanz, PhD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pennsylvania
Authority:
United States: Institutional Review Board
Study ID:
PennSCAPE
NCT ID:
NCT01356771
Start Date:
May 2011
Completion Date:
December 2011
Related Keywords:
- Melanoma
- Skin Cancer
- Risk Assessment
- Intervention
- Skin Neoplasms
- Melanoma
Name | Location |
|---|---|
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
