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Tailored Intervention for Melanoma Patient's Families

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reading materials and discussions
Reading materials and discussions
Questionnaires
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Melanoma focused on measuring cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR, skin cancer protection, skin cancer screening

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • H. Lee Moffitt Cancer Center & Research Institute
  • University of Pennsylvania
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Group I

Group II

Outcomes

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.

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.

Full Information

First Posted
December 31, 2008
Last Updated
May 15, 2014
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00816374
Brief Title
Tailored Intervention for Melanoma Patient's Families
Official Title
Tailored Intervention for Melanoma Patient's Families
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
cutaneous malignant melanoma, CMM, total cutaneous examination, TCE, skin self-examination, SSE, first degree relatives, FDR, skin cancer protection, skin cancer screening

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
553 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Group I
Arm Title
2
Arm Type
Other
Arm Description
Group II
Intervention Type
Other
Intervention Name(s)
Reading materials and discussions
Other Intervention Name(s)
Supportive Care Intervention, Behavioral
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Reading materials and discussions
Other Intervention Name(s)
Supportive Care Intervention, Behavioral
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Supportive Care Intervention, Behavioral
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Jacobsen, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Ming, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22082038
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.
Results Reference
background
PubMed Identifier
21090893
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.
Results Reference
result
PubMed Identifier
21338483
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.
Results Reference
result

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Tailored Intervention for Melanoma Patient's Families

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