Measuring Real Time Decision-Making About Ultraviolet Radiation (UVR) Protection - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborators:	University of British Columbia San Diego State University Stony Brook University
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01004952

Purpose

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.

Condition	Intervention
Melanoma	Behavioral: screening questionnaire

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Measuring Real Time Decision-Making About UVR Protection

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Sun Exposure

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To generate models explaining decision-making about four UVR protection behaviors (sunscreen use, shade-seeking, hat use, use of protective clothing) in melanoma FDRs. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	85
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 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.

Groups/Cohorts

Assigned Interventions

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

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.

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 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.

Criteria

Inclusion Criteria:

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.
18 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 daily (weekend and weekday) outdoor activities on the screening questionnaire

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004952

Contacts

Contact: Jennifer Hay, PhD	646-888-0039
Contact: Jack Burkhalter, PhD

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Jennifer Hay, PhD 646-888-0039

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University of British Columbia

San Diego State University

Stony Brook University

Investigators

Principal Investigator:

Jennifer Hay, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01004952 History of Changes
Other Study ID Numbers:	09-137
Study First Received:	October 29, 2009
Last Updated:	January 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Skin
Sunscreen
UVR Protection
09-137

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012