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Study Summary
No. 2003-0901:.......Melanoma......Ellen R. Gritz......Behavioral Science
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Study Summary Title
Study Summary
Number:		2003-0901
Study Title:A Targeted, Family-Focused Intervention for Melanoma Prevention
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Physician New Patient Referral
Name:Ellen R. GritzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2677
Contact us about clinical trials
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General Information
Disease Group:MelanomaSupported By:N/A
Phase of Study:N/AReturn
Visit:		Not applicable.
Treatment
Agents:		NoneHome Care:Participants may complete interviews by telephone. Participants in part 3 of
the study will receive information on melanoma risk-reduction mailed to the
home.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Not applicable.
Description/
Intervention:		Unvailable
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Study Objectives / Outcomes
In this study, we will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. We will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. We will evaluate the intervention in a randomized, controlled trial. The specific aims of this study are:

1. To interview 210 melanoma patients with children 12 years of age or younger to describe patients' socio-cognitive and psychological factors, describe patients' and children's sun exposure and sun protection practices, and identify determinants of patients' and children's sun exposure and protective practices.
2. To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure, increase patients' self-protective practices, decrease the sun exposure levels of patients and their children, and positively influence socio-cognitive and psychological determinants of child-centered and self-protective practices.
3. To conduct a randomized, controlled trial in a sample of 360 melanoma patients with children 12 years of age or younger to evaluate the targeted behavioral intervention consisting of print and video materials. The intervention will be assessed for its effects on: 1) child sun exposure and sun protection, 2) patients' protective practices to reduce their children's sun exposure; 3) patients' sun exposure and self-protective practices; and 4) patients' socio-cognitive and psychological factors that facilitate behavior change.
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Study Status Information
Study Activation / Registration Date:04/19/2005
IRB Review and Approval Date:11/19/2003
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:570
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988.

2) Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child.

3) Melanoma patients are eligible if they provide informed consent.

4) Melanoma patients are eligible if they are 18 years of age or older.

5) Melanoma patients are eligible if they are able to speak, read, and write English.

6) Melanoma patients are eligible if they meet all inclusion criteria.
Exclusion Criteria:1) Melanoma patients are not eligible if they cannot provide informed consent.
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Links
Registration Number: NCT00394134
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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