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| Tracking Information | |||||
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| First Received Date ICMJE | July 31, 2007 | ||||
| Last Updated Date | July 28, 2009 | ||||
| Start Date ICMJE | November 2002 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00510302 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Melanoma Risk-Reduction Among Patients and Family Members | ||||
| Official Title ICMJE | Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members | ||||
| Brief Summary | Primary Objectives:
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Family-Based, Prospective | ||||
| Condition ICMJE | Melanoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs). | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00510302 | ||||
| Responsible Party | Ellen R. Gritz, PhD/Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | ID02-452 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | American Cancer Society | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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