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Targeted Intervention for Melanoma Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394134
First Posted: October 31, 2006
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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.

Condition Intervention
Melanoma Behavioral: Interview

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Targeted, Family-Focused Intervention for Melanoma Prevention

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 570
Actual Study Start Date: April 2005
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394134


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Susan Peterson, PHD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00394134     History of Changes
Other Study ID Numbers: 2003-0901
First Submitted: October 27, 2006
First Posted: October 31, 2006
Last Update Posted: May 22, 2017
Last Verified: May 2017

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
Sun Exposure
Sun Protection
Interview

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas