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Melanoma Risk-Reduction Among Patients and Family Members

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00510302
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment
Melanoma Behavioral: Questionnaire Behavioral: Interview

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 Design
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Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members
Actual Study Start Date : November 18, 2002
Actual Primary Completion Date : September 14, 2020
Actual Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Groups and Cohorts
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Group/Cohort Intervention/treatment
Melanoma Risk-Reduction
Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
 Behavioral: Questionnaire
Questionnaire regarding melanoma risk-reduction.
Other Name: Survey

Behavioral: Interview
Interview via telephone about topics related to melanoma risk-reduction.


Outcome Measures
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Primary Outcome Measures :
  1. Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members [ Time Frame: 8 Years ]

Secondary Outcome Measures :
  1. Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population [ Time Frame: 8 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
Criteria

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.
  • A melanoma patient's FDR is eligible if he/she is a sibling or child of the melanoma patient.

Exclusion Criteria:

  • Melanoma patients, spouses/partners of patients, and FDRs of patients are not eligible if they cannot provide informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510302


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Susan Peterson, PhD M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00510302    
Other Study ID Numbers: ID02-452
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Ultraviolet Radiation
Melanoma
Questionnaire
 Survey
First Degree Relative
Interview
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas