Melanoma Risk-Reduction Among Patients and Family Members - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	American Cancer Society
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00510302

Purpose

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	Intervention
Melanoma	Behavioral: Questionnaire Behavioral: Interview

Study Type:	Observational
Study Design:	Family-Based, Prospective
Official Title:	Melanoma Risk-Reduction Practices Among Melanoma Patients and Their Family Members

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	170
Study Start Date:	November 2002
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Melanoma Risk-Reduction Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).	Behavioral: Questionnaire Questionnaire regarding melanoma risk-reduction. Behavioral: Interview Interview via telephone about topics related to melanoma risk-reduction.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Exclusion Criteria:

Melanoma patients, spouses/partners of patients, and FDRs of patients are not eligible if they cannot provide informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510302

Contacts

Contact: Ellen R. Gritz, PhD

713-745-2677

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Ellen R. Gritz, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

American Cancer Society

Investigators

Principal Investigator:

Ellen R. Gritz, PhD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Ellen R. Gritz, PhD/Professor )
Study ID Numbers:	ID02-452
Study First Received:	July 31, 2007
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00510302 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Ultraviolet Radiation
Melanoma
Questionnaire

Survey
First Degree Relative
Interview

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Nevi and Melanomas

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Melanoma
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on February 08, 2010