Targeted Intervention for Melanoma Prevention - Full Text View

Purpose

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:

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.
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.
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.

Condition	Intervention
Melanoma	Other: Interview

MedlinePlus related topics:

Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Official Title:	A Targeted, Family-Focused Intervention for Melanoma Prevention

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure and increase patients' self-protective practices. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To develop a targeted behavioral intervention that is designed to 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. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	570
Study Start Date:	April 2005
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Interview	Other: Interview Interviews to describe the sun exposure and sun protection practices of patients and their children.

Detailed Description:

We are interested in learning about awareness, attitudes, and behaviors related to sun exposure, sun protection, skin examination, and other risk-reducing behaviors. The results of this study will be used to design an educational program on sun protection for persons who have had melanoma and their children.

The study will involve a telephone interview that will last about 45 minutes and will be scheduled at your convenience. Your participation in this study is completely voluntary and you may refuse to participate. Your decision about participating will not affect the care or services you or your family may receive at The University of Texas M. D. Anderson Cancer Center.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988.
Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child.
Melanoma patients are eligible if they provide informed consent.
Melanoma patients are eligible if they are 18 years of age or older.
Melanoma patients are eligible if they are able to speak, read, and write English.
Melanoma patients are eligible if they meet all inclusion criteria.

Exclusion:

1) Melanoma patients are not eligible if they cannot provide informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394134

Contacts


Contact: Ellen R. Gritz, PhD	713-745-2677

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Ellen R. Gritz, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

American Cancer Society

Investigators


Principal Investigator:	Ellen R. Gritz, PhD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Ellen R. Gritz, PhD/Professor )
Study ID Numbers:	2003-0901
First Received:	October 27, 2006
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00394134
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Melanoma

Sun Exposure

Sun Protection

Interview

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center American Cancer Society
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00394134