Tailored Intervention for Melanoma Patient's Families

NCT00816374 | Completed

• 2 other identifiers: FCCC- 05-805IRB 05-805
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

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.

  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.

  approximately 9 months per participant

Study Arms (2)

1

OTHER

Group I

Other: Reading materials and discussions; Other: Questionnaires

2

OTHER

Group II

Other: Reading materials and discussions; Other: Questionnaires

Interventions

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.

Also known as: Supportive Care Intervention, Behavioral

1

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

Also known as: Supportive Care Intervention, Behavioral

1; 2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (3)

• Coups EJ, Manne SL, Jacobsen PB, Ming ME, Heckman CJ, Lessin SR. Skin surveillance intentions among family members of patients with melanoma. BMC Public Health. 2011 Nov 14;11:866. doi: 10.1186/1471-2458-11-866.

  PMID: 22082038 BACKGROUND

• Manne S, Jacobsen PB, Ming ME, Winkel G, Dessureault S, Lessin SR. Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients. Health Psychol. 2010 Nov;29(6):583-93. doi: 10.1037/a0021387.

  PMID: 21090893 RESULT

• Manne SL, Coups EJ, Jacobsen PB, Ming M, Heckman CJ, Lessin S. Sun protection and sunbathing practices among at-risk family members of patients with melanoma. BMC Public Health. 2011 Feb 21;11:122. doi: 10.1186/1471-2458-11-122.

  PMID: 21338483 RESULT

MeSH Terms

Conditions

Melanoma; Melanoma, Cutaneous Malignant

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; Skin Neoplasms; 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

• 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

  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: December 31, 2008
• First Posted: January 1, 2009
• Study Start: August 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

US (3)