Melanoma Risk Assessment & Tailored Intervention

NCT01356771 | Completed

• 2 other identifiers: PennSCAPE5UC2CA148310-02
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Skin Cancer

Keywords

Risk Assessment; Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

OTHER

Other: Surveys & Mailed Materials

Tailored Intervention

OTHER

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.

Other: Surveys & Mailed Materials

Interventions

Surveys & Mailed Materials 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

Control Group; Tailored Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen Glanz, PhD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

US (1)