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Melanoma Risk-Reduction Among Patients and Family Members
This study is currently recruiting participants.
Study NCT00510302   Information provided by M.D. Anderson Cancer Center
First Received: July 31, 2007   Last Updated: July 28, 2009   History of Changes

July 31, 2007
July 28, 2009
November 2002
November 2010   (final data collection date for primary outcome measure)
To collect information on the ultraviolet radiation (UVR-E) reduction and early detection practices of melanoma patients and their family members. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
The purpose of this study is to collect information on the ultraviolet radiation (UVR-E) reduction and early detection practices of melanoma patients and their family members. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00510302 on ClinicalTrials.gov Archive Site
Findings from this study will inform the development and refinement of questionnaires and tailored intervention messages on the topic of melanoma risk-reduction in a high-risk population. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Same as current
 
Melanoma Risk-Reduction Among Patients and Family Members
Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members

Primary Objectives:

  • To conduct semi-structured interviews with melanoma patients and family members to collect descriptive information on their UVR exposure, UVR exposure-reduction practices, melanoma early detection practices, knowledge, psychosocial variables related to melanoma risk-reduction (e.g., self-efficacy, norms, and expectations), and experiences surrounding the diagnosis of melanoma in the family. Melanoma patients and family members with children will be asked about the UVR exposure and UVR exposure-reduction practices of their children, and parental practices to reduce UVR exposure among children.
  • To develop behavioral and attitudinal questionnaires based on data collected during semi-structured interviews, and evaluate the appropriateness of these questionnaires using cognitive interviewing techniques.
  • To develop tailored messages aimed at promoting strategies to reduce UVR exposure (e.g., wearing protective clothing, minimizing midday UVR exposure, minimizing duration of UVR exposure, using shade and sunscreen, avoiding sun lamps, and avoiding intentional tanning) and improving adherence to surveillance and screening guidelines. Messages will be developed to correspond to responses to questionnaire items.
  • To assess tailored messages for their relevance, appropriateness, attractiveness and appeal, credibility, and perceived behavioral impact among melanoma patients and their family members.

Participants in Part 1 of the study will be asked to be interviewed about topics related to melanoma risk-reduction, including opinions, attitudes, beliefs, and practices related to ultraviolet radiation exposure, melanoma prevention, and melanoma detection.

Participants in Part 2 of the study will be asked to complete a written questionnaire on melanoma risk-reduction and then be interviewed to obtain feedback on how the questionnaire may be refined.

Participants in Part 3 of the study will be asked to be interviewed by telephone. Participants then will receive educational material in the form of a newsletter tailored to their interview responses. Participants then will be asked to be interviewed to obtain feedback for refining the educational material. In each part of the study, the patient/family member will receive a letter describing the study and the Consent Statement for Questionnaire and Interview Studies.

Prior to the start of the interview, the Consent Statement will be read to the patient/family member. Patients/family members may or may not choose to have the interview tape-recorded. Participants may stop the interview or questionnaire at any time and may refuse to answer any questions. At any time, the patient/family member may refuse to have the interview tape-recorded. There is no treatment associated with this study.

 
Observational
Family-Based, Prospective
Melanoma
  • Behavioral: Questionnaire
  • Behavioral: Interview
Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
170
 
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • (FDRs will include siblings and adult children.) Melanoma patients are eligible if they were diagnosed with in situ, localized, or regional melanoma after January 1, 1997.
  • Melanoma patients, their spouses/partners, and their first-degree relatives (FDRs) 18 years of age or older are eligible.
  • Melanoma patients, their spouses/partners, and FDRs are eligible if they can speak, read, and write English.
  • Melanoma patients, their spouses/partners, and FDRs are eligible if they provide informed consent.
  • Spouses/partners and FDRs of melanoma patients are eligible if the patient gives permission for them to be contacted for recruitment.

Exclusion Criteria:

  • Melanoma patients, spouses/partners of patients, and FDRs of patients are not eligible if they cannot provide informed consent.
Both
18 Years and older
Yes
Contact: Ellen R. Gritz, PhD 713-745-2677
United States
 
NCT00510302
Ellen R. Gritz, PhD/Professor, U.T.M.D. Anderson Cancer Center
ID02-452
M.D. Anderson Cancer Center
American Cancer Society
Principal Investigator: Ellen R. Gritz, PhD U.T.M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2009

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