Clinical trial NCT00394134: Targeted Intervention for Melanoma Prevention
Official title: A Targeted, Family-Focused Intervention for Melanoma Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: Melanoma
Sun Exposure
Sun Protection
Interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2006-10-31
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Patients'and Children's Sun Exposure and Protective Practices <Patient Interview Responses>
timeFrame: Baseline Interview, 6 Month and 9 Month Interviews
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan Peterson, PHD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.