Targeted Intervention for Melanoma Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00394134
First received: October 27, 2006
Last updated: December 17, 2012
Last verified: December 2012

October 27, 2006
December 17, 2012
April 2005
April 2014   (final data collection date for primary outcome measure)
Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses> [ Time Frame: Baseline Interview, 6 Month and 9 Month Interviews ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00394134 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Targeted Intervention for Melanoma Prevention
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Melanoma
Behavioral: Interview
Interviews to describe the sun exposure and sun protection practices of patients and their children.
Interview
Interviews to describe the sun exposure and sun protection practices of patients and their children.
Intervention: Behavioral: Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
570
Not Provided
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Melanoma patients are eligible if they:

  1. Were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988.
  2. Are the parent of a child 12 years of age or younger and reside with the child.
  3. Provide informed consent.
  4. Are 18 years of age or older.
  5. Are able to speak, read, and write English.
  6. Meet all inclusion criteria.

Exclusion Criteria:

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394134
2003-0901
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP