Clinical trial NCT00816374: Tailored Intervention for Melanoma Patient's Families
Official title: Tailored Intervention for Melanoma Patient's Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-01-01
Enrollment: 553
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: approximately 9 months per participant
Secondary outcomes:
measure: 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.
timeFrame: approximately 9 months per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Paul Jacobsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fox Chase Cancer Center
name: Sharon L Manne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Michael Ming, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.