MelanomaPennSCAPENCT01356771
Melanoma Risk Assessment & Tailored Intervention
A study testing Surveys & Mailed Materials in people with Melanoma and Skin Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators are conducting a study to provide evidence about the comparative effectiveness of mailed, tailored intervention materials on cancer prevention behavioral outcomes. The investigators will send out three (3) tailored mailings for participants who are assigned to the intervention group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Skin Cancer
- What is being tested?
- Surveys & Mailed Materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- To be included in Phase I, a subject must meet all of the following criteria:
- Subjects are capable of giving informed consent
- Subjects are ≥ 18 years old.
- Subjects are English speaking and can read English
- To be included for analysis during Phase II, a subject must meet all of the following criteria:
- Subjects must meet all criteria listed in Phase I.
- Subjects are identified as Caucasian.
- Subjects must be at moderate or high risk for skin cancer, based on scores from the BRAT and Fears combined risk assessment.
Who cannot join
- Children under the age of 18 will not be included.
- For Phase II, previously diagnosed with melanoma.
- For Phase II, planning to be away for three (3) consecutive weeks or longer in June, July, or August
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
The investigators are conducting a study to provide evidence about the comparative effectiveness of mailed, tailored intervention materials on cancer prevention behavioral outcomes. The investigators will send out three (3) tailored mailings for participants who are assigned to the intervention group. Second, during the eligibility screening, the investigators will be assessing the relative yield and functioning of two risk assessment tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.
Read the detailed description
This study aims to evaluate the impact of a mailed, tailored intervention, on the skin cancer prevention and skin self-examination behaviors of high-risk and moderate-risk adults. Participants will be recruited in primary health care setting (Penn Radnor Clinic) after their scheduled appointment. During Phase I of this study, patients will be screened for their level of risk for skin cancer. They will be asked to complete a survey as well as undergo a quick skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II of the study, and will then complete a baseline survey either in person, over the phone, or via mail after they have consented. After completing a baseline survey, these participants will be randomized to receive tailored materials, including personalized risk feedback, or to a control group that will receive generic educational materials. Participants will then be re-assessed at follow-up approximately three (3) months later via a mailed survey.
The intervention consists of one to three sets of intervention materials, depending on if they are randomized to the generic group or the tailored group. The first mailing will be sent out approximately two weeks after a participant completes the baseline survey, and is designed to educate participants on ways to prevent skin cancer though personalized behavioral changes. The second mailing will be sent out two weeks after the first mailing, and is designed to provide a guide to participants on steps to complete a skin self exam. Finally, the third mailing will be sent out two weeks after the second mailing, and will provide medical information to the participants regarding types of skin cancer along with tips to remember that encompass information from previous mailings.
Finally, the participant will complete a follow-up survey approximately one (1) month after the last mailing has been mailed.
- Conditions
- Melanoma, Skin Cancer
- Being tested
- Surveys & Mailed Materials
- Keywords
- Risk Assessment, Intervention
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveys & Mailed MaterialsOther
Phase I: Patients are screened for their level of risk for skin cancer. They will complete a survey and undergo a skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II.
Phase II: Three sets of materials will be sent in the mail over the course of 6 weeks. Pamphlets will contain information about ways to reduce participant's risk of skin cancer, including sun protection practices, benefits of skin screening practices, and how to do skin self-examinations.
The participant will also complete two surveys for this study, one at baseline and then one at follow up approximately three months later.
Each survey will ask the participant about:
- Current and past skin cancer screening practices
- Current and past sun protection practices
- Attitudes about skin cancer and sun protection
- Knowledge of melanoma
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | Not described Receives: Other: Surveys & Mailed Materials |
| Tailored Intervention | Other | We will mail three separate pamphlets created specifically for the participant. The information in the pamphlets will be based on answers from the first survey. Receives: Other: Surveys & Mailed Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effects of offering tailored print materials to that of generic print materials on perceived risk of melanoma, sun avoidance/protection, and skin self-examination behaviors.
In Phase II of this study, we will conduct a randomized trial to compare the effects of a tailored intervention to a standard intervention of brochures with risk communication, skin cancer prevention, and skin cancer detection information. Outcomes are sun protection, sun exposure, frequency of sunburns, and skin examinations. Subjects in Phase II will be adults at moderate and high risk for skin cancer based on the scores they received from the risk assessment in Phase I.
Measured: 3-6 months total per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Glanz, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356771
- Sponsor's protocol ID
- PennSCAPE
- Other IDs
- 5UC2CA148310-02
- Acronym
- PennSCAPE
- Status last verified
- Aug 2016
- First submitted
- 29 Apr 2011
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Risk Assessment and Skin Cancer Awareness, Prevention, and Education in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT01356771
- Acronym / sponsor ID
- PennSCAPE / PennSCAPE
- Conditions
- Melanoma, Skin Cancer
- Keywords
- Risk Assessment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting a study to provide evidence about the comparative effectiveness of mailed, tailored intervention materials on cancer prevention behavioral outcomes. The investigators will send out three (3) tailored mailings for participants who are assigned to the intervention group. Second, during the eligibility screening, the investigators will be assessing the relative yield and functioning of two risk assessment tools (BRAT and FEARS) on determining an individual's level of risk for skin cancer.
Detailed description
This study aims to evaluate the impact of a mailed, tailored intervention, on the skin cancer prevention and skin self-examination behaviors of high-risk and moderate-risk adults. Participants will be recruited in primary health care setting (Penn Radnor Clinic) after their scheduled appointment. During Phase I of this study, patients will be screened for their level of risk for skin cancer. They will be asked to complete a survey as well as undergo a quick skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II of the study, and will then complete a baseline survey either in person, over the phone, or via mail after they have consented. After completing a baseline survey, these participants will be randomized to receive tailored materials, including personalized risk feedback, or to a control group that will receive generic educational materials. Participants will then be re-assessed at follow-up approximately three (3) months later via a mailed survey.
The intervention consists of one to three sets of intervention materials, depending on if they are randomized to the generic group or the tailored group. The first mailing will be sent out approximately two weeks after a participant completes the baseline survey, and is designed to educate participants on ways to prevent skin cancer though personalized behavioral changes. The second mailing will be sent out two weeks after the first mailing, and is designed to provide a guide to participants on steps to complete a skin self exam. Finally, the third mailing will be sent out two weeks after the second mailing, and will provide medical information to the participants regarding types of skin cancer along with tips to remember that encompass information from previous mailings.
Finally, the participant will complete a follow-up survey approximately one (1) month after the last mailing has been mailed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: Surveys & Mailed Materials |
| Tailored Intervention | Other | Other: Surveys & Mailed MaterialsWe will mail three separate pamphlets created specifically for the participant. The information in the pamphlets will be based on answers from the first survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects are capable of giving informed consent
- Subjects are ≥ 18 years old.
- Subjects are English speaking and can read English
- To be included for analysis during Phase II, a subject must meet all of the following criteria:
- Subjects must meet all criteria listed in Phase I.
Key exclusion criteria (3 listed)
- Children under the age of 18 will not be included.
- For Phase II, previously diagnosed with melanoma.
- For Phase II, planning to be away for three (3) consecutive weeks or longer in June, July, or August
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 |
|---|---|---|
| Surveys & Mailed MaterialsPhase I: Patients are screened for their level of risk for skin cancer. They will complete a survey and undergo a skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II. Phase II: Three sets of materials will be sent in the mail over the course of 6 weeks. Pamphlets will contain information about ways to reduce participant's risk of skin cancer, including sun protection practices, benefits of skin screening practices, and how to do skin self-examinations. The participant will also complete two surveys for this study, one at baseline and then one at follow up approximately three months later. Each survey will ask the participant about: * Current and past skin cancer screening practices * Current and past sun protection practices * Attitudes about skin cancer and sun protection * Knowledge of melanoma | Other | Control Group, Tailored Intervention |
Primary outcome
Compare the effects of offering tailored print materials to that of generic print materials on perceived risk of melanoma, sun avoidance/protection, and skin self-examination behaviors.
Time frame: 3-6 months total per participant
In Phase II of this study, we will conduct a randomized trial to compare the effects of a tailored intervention to a standard intervention of brochures with risk communication, skin cancer prevention, and skin cancer detection information. Outcomes are sun protection, sun exposure, frequency of sunburns, and skin examinations. Subjects in Phase II will be adults at moderate and high risk for skin cancer based on the scores they received from the risk assessment in Phase I.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
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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.
Karen Glanz, PhD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys & Mailed Materials in people with Melanoma and Skin Cancer, run by University of Pennsylvania 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 8 inclusion and 3 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 19 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the effects of offering tailored print materials to that of generic print materials on perceived risk of melanoma, sun avoidance/protection, and skin self-examination behaviors. (time frame: 3-6 months total per participant). 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 19 Aug 2016; AzTrials last refreshed its copy on 3 Nov 2026.