Tailored Intervention for Melanoma Patient's Families - Full Text View

Sponsors and Collaborators:	Fox Chase Cancer Center National Cancer Institute (NCI)
Information provided by:	Fox Chase Cancer Center
ClinicalTrials.gov Identifier:	NCT00816374

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:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Tailored Intervention for Melanoma Patient's Families

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Skin Cancer

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 ]

Estimated Enrollment:	1165
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 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: 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
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: 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

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: 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

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: 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

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	Recruiting
Tampa, Florida, United States, 33612
Contact: Christine Marsella 813-745-1810 christine.marsella@moffitt.org
Principal Investigator: Paul Jacobsen, Ph.D.
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Sara Worhach, MS 215-214-3794 sara.worhach@fccc.edu
Principal Investigator: Sharon L Manne, PhD
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Emily Weitberg weitberg@mail.med.upenn.edu
Principal Investigator: Michael Ming, MD

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

Additional Information:

Moffitt Cancer Center Clinical Trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Fox Chase Cancer Center ( Sharon Manne, Ph.D. )
Study ID Numbers:	FCCC- 05-805, IRB 05-805
Study First Received:	December 31, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00816374 History of Changes
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

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus

Skin Neoplasms
Melanoma, Familial
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on September 02, 2009