Melanoma Risk-Reduction Among Patients and Family Members

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00510302
First received: July 31, 2007
Last updated: January 27, 2014
Last verified: January 2014

July 31, 2007
January 27, 2014
November 2002
November 2015   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00510302 on ClinicalTrials.gov Archive Site
Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population [ Time Frame: 8 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).

Melanoma
  • Behavioral: Questionnaire
    Questionnaire regarding melanoma risk-reduction.
    Other Name: Survey
  • Behavioral: Interview
    Interview via telephone about topics related to melanoma risk-reduction.
Melanoma Risk-Reduction
Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).
Interventions:
  • Behavioral: Questionnaire
  • Behavioral: Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
Not Provided
November 2015   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00510302
ID02-452
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
January 2014

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