Clinical trial NCT01356771: Melanoma Risk Assessment & Tailored Intervention
Official title: Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Skin Cancer
Keywords: Risk Assessment
Intervention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-19
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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.
timeFrame: 3-6 months total per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Karen Glanz, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: