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Completed

NCT Number: NCT00816374

Tailored Intervention for Melanoma Patient's Families

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reading materials and discussions

Other

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.

Other names: Supportive Care Intervention, Behavioral

questionnaires

Other

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

Other names: Supportive Care Intervention, Behavioral

Primary outcomes

  1. 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.

    Time frame: approximately 9 months per participant

Secondary outcomes

  1. 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.

    Time frame: approximately 9 months per participant

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 1, 2009
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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