MelanomaNCT01004952
Measuring Real Time Decision-Making About Ultraviolet Radiation (UVR) Protection
An observational study of Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- screening questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2009to 6 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Measuring Real Time Decision-Making About UVR Protection
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.
- Conditions
- Melanoma
- Being tested
- screening questionnaire
- Keywords
- Skin, Sunscreen, UVR Protection, 09-137
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: screening questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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. Phase 1 was not assessed for this Outcome Measure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study start27 Oct 2009
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, San Diego State University, Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Jennifer Hay, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004952
- Sponsor's protocol ID
- 09-137
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2009
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Real Time Decision-Making About UVR Protection
- ClinicalTrials.gov ID
- NCT01004952
- Acronym / sponsor ID
- 09-137
- Conditions
- Melanoma
- Keywords
- Skin, Sunscreen, UVR Protection, 09-137
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of British Columbia, San Diego State University, Stony Brook University
- Study start
- 27 Oct 2009 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| screening questionnaire | – | Behavioral: screening questionnaireThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening questionnairePhase 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. | Behavioural | screening questionnaire |
Primary outcome
Number of Participants Interviewed on UVR Protection Behaviors.
Time frame: 1 year
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 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hay, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Interviewed on UVR Protection Behaviors. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.