Melanoma Risk-Reduction Among Patients and Family Members

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00510302

Collaborator

(none)

170

Enrollment

Location

213.9

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Nov 18, 2002

Actual Primary Completion Date :

Sep 14, 2020

Actual Study Completion Date :

Sep 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Melanoma Risk-Reduction Patients with melanoma, their spouses/partners, and first-degree relatives (FDRs).	Behavioral: Questionnaire Questionnaire regarding melanoma risk-reduction. Other Names: Survey Behavioral: Interview Interview via telephone about topics related to melanoma risk-reduction.

Arm

Intervention/Treatment

Melanoma Risk-Reduction

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

Behavioral: Questionnaire

Questionnaire regarding melanoma risk-reduction.

Other Names:

Survey

Behavioral: Interview

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

Outcome Measures

Primary Outcome Measures

Information on ultraviolet radiation (UVR-E) reduction + early detection practices of melanoma patients and family members [8 Years]

Secondary Outcome Measures

Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population [8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,

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.