Tailored Intervention for Melanoma Patient's Families

Study Overview
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Brief Summary
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The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.

Detailed Description
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Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study. Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.

Official Title
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Tailored Intervention for Melanoma Patient's Families

Conditions
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Melanoma

Intervention / Treatment
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* Other: Reading materials and discussions
* Other: Reading materials and discussions
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Patients (for referral of FDRs): Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics Greater than 18 years of age English speaking Able to give meaningful informed consent Does NOT have a first-degree relative with CMM Inclusion Criteria - FDR (First Degree Relative): Current age of at least 21 years One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis Able to give informed consent English speaking Has residential phone service No personal history of CMM or non-melanoma skin cancer No personal history of dysplastic nevi Exclusion Criteria - FDR: 2 or more first degree relatives with CMM Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Group I | Other: Reading materials and discussions<br>* We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by: The American Cancer Society The American Academy of Dermatology The Skin Cancer Foundation The pamphlets contain information about ways to reduce risk for skin cancer including: Sun protection practices Risk factors for melanoma Information about what melanoma looks like How to do skin self-examinations There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.<br>* Other names: Behavioral;Other: Questionnaires<br>* Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about: knowledge of melanoma current and past skin cancer screening practices current and past sun protection practices attitudes about skin cancer and sun protection feelings about relative's melanoma diagnosis and treatment<br>* Other names: Behavioral;|
| Other: 2<br>Group II | Other: Reading materials and discussions<br>* We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about: Melanoma and skin cancer protection guidelines The benefits of skin screening practices Ways to protect yourself from the sun In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.<br>* Other names: Behavioral;Other: Questionnaires<br>* Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about: knowledge of melanoma current and past skin cancer screening practices current and past sun protection practices attitudes about skin cancer and sun protection feelings about relative's melanoma diagnosis and treatment<br>* Other names: Behavioral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM. |  | approximately 9 months per participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection. |  | approximately 9 months per participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR, skin cancer protection, skin cancer screening