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Targeted Intervention for Melanoma Prevention

Primary Purpose

Melanoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interview
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Melanoma focused on measuring Melanoma, Sun Exposure, Sun Protection, Interview

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interview

Arm Description

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

Outcomes

Primary Outcome Measures

Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>
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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2006
Last Updated
September 11, 2019
Sponsor
M.D. Anderson Cancer Center
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00394134
Brief Title
Targeted Intervention for Melanoma Prevention
Official Title
A Targeted, Family-Focused Intervention for Melanoma Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2005 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Sun Exposure, Sun Protection, Interview

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interview
Arm Type
Other
Arm Description
Interviews to describe the sun exposure and sun protection practices of patients and their children.
Intervention Type
Behavioral
Intervention Name(s)
Interview
Intervention Description
Interviews to describe the sun exposure and sun protection practices of patients and their children.
Primary Outcome Measure Information:
Title
Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>
Description
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.
Time Frame
Baseline Interview, 6 Month and 9 Month Interviews

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 1) Melanoma patients are not eligible if they cannot provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Peterson, PHD, MPH
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24097199
Citation
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Targeted Intervention for Melanoma Prevention

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