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Tailored Intervention for Melanoma Patient's Families

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sara Worhach, Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00816374
First received: December 31, 2008
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Melanoma
 Other: Reading materials and discussions
Other: Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Tailored Intervention for Melanoma Patient's Families

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 553
Study Start Date: August 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Group I
 Other: Reading 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.

Other Names:
  • Supportive Care Intervention
  • Behavioral
Other: Questionnaires

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
2
Group II
 Other: Reading materials and discussions

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.

Other Names:
  • Supportive Care Intervention
  • Behavioral
Other: Questionnaires

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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816374

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul Jacobsen, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Sharon L Manne, PhD Fox Chase Cancer Center
Principal Investigator: Michael Ming, MD University of Pennsylvania
  More Information

Publications:

Responsible Party: Sara Worhach, Project Manager, Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00816374     History of Changes
Other Study ID Numbers: FCCC- 05-805, IRB 05-805
Study First Received: December 31, 2008
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:
cutaneous malignant melanoma
CMM
total cutaneous examination
TCE
skin self-examination
 SSE
first degree relatives
FDR
skin cancer protection
skin cancer screening

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 18, 2013