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Tailored Intervention for Melanoma Patient's Families

Tailored Intervention for Melanoma Patient's Families

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00816374
Enrollment
553
Registered
2009-01-01
Start date
2005-08-31
Completion date
2011-05-31
Last updated
2014-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR, skin cancer protection, skin cancer screening

Brief summary

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

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.

Interventions

OTHERReading materials and discussions

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.

OTHERQuestionnaires

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fox Chase Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026