Tailored Intervention for Melanoma Patient's Families

Melanoma Clinical Trial

Official title:

Tailored Intervention for Melanoma Patient's Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816374
• Other study ID #: FCCC- 05-805
• Secondary ID: IRB 05-805
• Status: Completed
• Phase: N/A
• First received: December 31, 2008
• Last updated: May 15, 2014
• Start date: August 2005
• Est. completion date: May 2011

Study information

• Verified date: May 2014
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No