Targeted Intervention for Melanoma Prevention

NCT ID: NCT00394134

Last Updated: 2019-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2019-08-26

Brief Summary

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In this study, the researchers will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. The researchers will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. The researchers 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.

Detailed Description

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Research is to learn 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.

Conditions

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Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Interview

Interviews to describe the sun exposure and sun protection practices of patients and their children.

Group Type OTHER

Interview

Intervention Type BEHAVIORAL

Interviews to describe the sun exposure and sun protection practices of patients and their children.

Interventions

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Interview

Interviews to describe the sun exposure and sun protection practices of patients and their children.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Exclusion Criteria

1\) Melanoma patients are not eligible if they cannot provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Peterson, PHD, MPH

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Gritz ER, Tripp MK, Peterson SK, Prokhorov AV, Shete SS, Urbauer DL, Fellman BM, Lee JE, Gershenwald JE. Randomized controlled trial of a sun protection intervention for children of melanoma survivors. Cancer Epidemiol Biomarkers Prev. 2013 Oct;22(10):1813-24. doi: 10.1158/1055-9965.EPI-13-0249.

Reference Type DERIVED
PMID: 24097199 (View on PubMed)

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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2003-0901

Identifier Type: -

Identifier Source: org_study_id

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