Melanoma Risk-Reduction Among Patients and Family Members
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 31, 2007 | ||||
| Last Updated Date | January 23, 2013 | ||||
| Start Date ICMJE | November 2002 | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members [ Time Frame: 8 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00510302 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population [ Time Frame: 8 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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:
|
||||
| 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs). |
||||
| Condition ICMJE | Melanoma | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) | Melanoma Risk-Reduction
Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
Interventions:
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00510302 | ||||
| Other Study ID Numbers ICMJE | ID02-452 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | American Cancer Society, Inc. | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | January 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||