Trial record 5 of 5 for:
Open Studies | "Sunscreening Agents"
Measuring Real Time Decision-Making About Ultraviolet Radiation (UVR) Protection
This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
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
First received: October 29, 2009
Last updated: January 15, 2013
Last verified: January 2013
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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:
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 2013 |
| Estimated Primary Completion Date: | October 2013 (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.
|
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 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
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 | 646-888-0040 |
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:
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 15, 2013 |
| 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, 2013