NCT01004952

Brief Summary

The purpose of this study is to understand how people make decisions about sun protection. This study is important in helping to protect against sun exposure, since it is a main risk factor for melanoma. The investigators would like to understand the decisions people make about sun protection so that they can improve their ability to help individuals who may be at risk for melanoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

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

October 27, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

July 1, 2025

Enrollment Period

14.9 years

First QC Date

October 29, 2009

Results QC Date

September 5, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

SkinSunscreenUVR Protection09-137

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Interviewed on UVR Protection Behaviors.

    To generate models explaining decision-making about four UVR protection behaviors (sunscreen use, shade-seeking, hat use, use of protective clothing) in melanoma FDRs. This was an inductive, qualitative study using an open-ended interview to accomplish the Aim. Cohort 1 was used for this Aim.

    1 year

Secondary Outcomes (1)

  • To Examine Theory-driven Affective and Cognitive Predictors of UVR Protection Maintenance (Sunscreen Use, Shade-seeking, Hat Use, and Use of UVR Protective Clothing)Assessed in Real Time.

    1 year

Study Arms (1)

screening questionnaire

This study will involve two phases. Guided by EDTM, we will first build models of decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing)using in-home ethnographic interviews with 25 melanoma FDRs (Phase I). In Phase II, we will test the validity of each composite model. This will be completed using EMA data collection with 60 different melanoma FDRs from Phase I who will report on their sunscreen use, shade-seeking, use of hat, and use of UVR protective clothing and decision-making regarding these outcomes via interactive voice response (IVR) system and audio narrative diaries (using a digital voice recorder). We will examine the validity of each model and examine the influence of theory-driven affective and cognitive predictors of UVR protection maintenance across time.

Behavioral: screening questionnaire

Interventions

Phase I involves in-home interviews of 25 participants to understand the factors that affect participants' decision-making about UVR protection (sunscreen use, shade-seeking, hat use, use of protective clothing). In Phase II, we plan to recruit a sample of 60 melanoma first degree relatives (FDRs) and use an electronic narrative diary to record their daily behaviors about UVR protection. They will be asked to carry a interactive voice response (IVR) system for 14 days and they should be in the continental United States.

screening questionnaire

Eligibility Criteria

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

Patients whose FDRs may be eligible for this study will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC) will identify patients who are melanoma patients.

You may qualify if:

  • A first-degree biological relative (a child, sibling or parent) as per self report of an MSKCC follow-up surgical patient diagnosed with melanoma as per pathology report or clinician's judgment;
  • English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
  • years of age or older;
  • For Phase I only: FDRs who live within a 50 mile radius of MSKCC to make it feasible for Ms. Shuk to be able to arrive at each person's home for the in-home interview without the cost being prohibitive;
  • For Phase I only: Can recall a period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009.
  • For Phase I only: Can recall a separate period when s/he was out in the sun for at least one hour on a sunny day this past summer 2009, but s/he was in a different location from the period referenced above.
  • For Phase II only: FDRs who self-report at least 1 consecutive hour in the morning (dawn to 12:30pm) and 1 consecutive hour in the afternoon (12:30-5pm) of daily (weekend and weekday) outdoor activities on the screening questionnaire

You may not qualify if:

  • First-degree relatives of melanoma patients who report never using UVR protection;
  • Patient's who provide consent for Phase I will not be eligible for Phase II.
  • Any first-degree relative of a melanoma patient who already has a first-degree relative who consented to the study;
  • Unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Melanoma

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

Results Point of Contact

Title
Dr. Jennifer Hay, PhD
Organization
Memorial Sloan Kettering Cancer Center

Study Officials

  • Jennifer Hay, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

October 29, 2009

First Posted

October 30, 2009

Study Start

October 27, 2009

Primary Completion

September 6, 2024

Study Completion

September 6, 2024

Last Updated

January 7, 2026

Results First Posted

January 7, 2026

Record last verified: 2025-07

Locations