NCT00510302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2002

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

17.8 years

First QC Date

July 31, 2007

Last Update Submit

September 14, 2020

Conditions

Keywords

Ultraviolet RadiationMelanomaQuestionnaireSurveyFirst Degree RelativeInterview

Outcome Measures

Primary Outcomes (1)

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

    8 Years

Secondary Outcomes (1)

  • Development of questionnaires + tailored intervention messages on melanoma risk-reduction in a high-risk population

    8 years

Study Arms (1)

Melanoma Risk-Reduction

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

Behavioral: QuestionnaireBehavioral: Interview

Interventions

QuestionnaireBEHAVIORAL

Questionnaire regarding melanoma risk-reduction.

Also known as: Survey
Melanoma Risk-Reduction
InterviewBEHAVIORAL

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

Melanoma Risk-Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Susan Peterson, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 2, 2007

Study Start

November 18, 2002

Primary Completion

September 14, 2020

Study Completion

September 14, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations