Targeted Intervention for Melanoma Prevention

September 11, 2019 updated by: M.D. Anderson Cancer Center

A Targeted, Family-Focused Intervention for Melanoma Prevention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interview
Interviews to describe the sun exposure and sun protection practices of patients and their children.
Behavioral: Interview
Interviews to describe the sun exposure and sun protection practices of patients and their children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>
Time Frame: Baseline Interview, 6 Month and 9 Month Interviews

Standard descriptive statistics computed for measures administered during structured interview, including means, standard deviations, ranges, measures of skew and kurtosis, together with 95% confidence intervals. Distributional characteristics of variables closely examined using boxplots, histograms, quantile-quantile plots, and the Kolmogorov-Smirnov test of normality.

General linear mixed-model approach used evaluate associations between patient socio-cognitive factors, psychological factors, phenotypic characteristics, and demographic characteristics; child phenotypic and demographic characteristics; and practices of participants to reduce their children's sun exposure, self-protective practices of participants, and sun exposure practices of children and participants.
Baseline Interview, 6 Month and 9 Month Interviews

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Susan Peterson, PHD, MPH, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2005

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

October 27, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

October 31, 2006

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-0901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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