MelanomaNCT02457065
Skin Care Behaviors Among Melanoma Survivors and Their Families
A study testing "Melanoma Survivor" plaque in people with Melanoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
A patient's sun-related behavior greatly influences the likelihood of that patient developing melanoma, the most dangerous form of skin cancer. Prior research shows current educational strategies on inducing preventative behaviors such as wearing sun-protection clothing and wearing sunscreen are inadequate at… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- "Melanoma Survivor" plaque
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patient has melanoma diagnosis within past 10 years less than 4mm in depth
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center (Heater Road)
Lebanon, New Hampshire, 03766
About this study
A patient's sun-related behavior greatly influences the likelihood of that patient developing melanoma, the most dangerous form of skin cancer. Prior research shows current educational strategies on inducing preventative behaviors such as wearing sun-protection clothing and wearing sunscreen are inadequate at effectively changing behavior when used in isolation -- patients are aware of the dangers of not engaging in these preventative measures but forgo them nonetheless.
The investigators are researching methods to positively influence skin cancer prevention behaviors among melanoma survivors and their families. The first objective of this study is to compare patient and familial sun exposure and cancer screening activity before and after a patient's diagnosis with primary melanoma. The second objective of this study is to note if hanging a "Melanoma Survivor" plaque in a melanoma survivor's bathroom will significantly affect the survivor's and broader family's sun exposure and cancer screening activity.
Read more
The investigators' sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and voluntarily chose to participate in the study after being informed of the nature of the research. These patients completed a confidential survey assessing sun exposure related activities immediately before and after their diagnosis. After the participants filled out the survey, the investigators asked the participants if they could nominate a family member to whom the investigators could explain the purpose of this research study to and confidentially ask an additional set of questions to evaluate the broader impact of a melanoma diagnosis. From the investigators' original sample, the investigators randomly chose a few families who would display the survivor plaque in their primary bathroom. After six-to-twelve months, during the each patient's follow up visit, the investigators asked the patient and the patient's nominated family member to fill out another survey to assess sun exposure related activity.
On the surveys, no names were recorded. Everything was anonymous.
Read the detailed description
This study is investigating a method to positively influence skin cancer prevention behaviors among melanoma survivors and their families. The first objective is to compare patient and familial sun exposure and cancer screening activity before and after a patient's diagnosis with primary cutaneous melanoma less than 4.0 mm in depth. It is believed that the diagnosis will positively affect behavior regarding skin cancer prevention as the diagnosis of melanoma makes the risk associated with sun-exposure and skin cancer a tangible issue. The second objective is to test whether receiving a "Melanoma Survivor" plaque and posting it in a melanoma survivor's bathroom will significantly affect the survivor's and broader family's sun exposure and cancer screening activity. Marketing research has shown similar techniques have been effective in causing individuals to consume goods (e.g. getting free pens with company logos makes you more likely to buy goods from that company), and the investigators think such techniques are transferable into the field of public health.
- Conditions
- Melanoma
- Being tested
- "Melanoma Survivor" plaque
- Keywords
- survivors, family
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Melanoma Survivor" plaqueBehavioural
Also called Receive Plaque
The investigators give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Receive Plaque | Experimental | Treatment
"Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors. Receives: Behavioral: "Melanoma Survivor" plaque |
| Do Not Receive Plaque | No intervention | Control No "Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of a Patient's Melanoma Diagnosis on the Survivor's and Broader Family's Skin Cancer Prevention Activity.
Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity before and after the patient's diagnosis with primary melanoma. Subjects self-reported if the diagnosis changed their behavior.
Measured: Collected via a survey administered immediately after a subject enrolled in the study.
Influence of a "Melanoma Survivor" Plaque on the Survivor's and Broader Family's Skin Cancer Prevention Activity.
Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. The investigators randomly gave some subjects a "Melanoma Survivor" plaque. After 6-12 months, the subjects again filled out a survey assessing their skin cancer prevention behaviors. The investigators analyzed the difference in each subject's responses to the same survey questions over time. The investigators then analyzed the difference between the responses of the subjects who saw the plaque and the subjects who did not see the plaque to discern the influence of the plaque on skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity. Subjects self-reported if the their behavior changed over time.
Measured: 6-12 months between time of completion of first survey and second survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
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 Dartmouth-Hitchcock Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael S. Chapman, Dartmouth-Hitchcock Medical Center
- Investigators
- Michael S Chapman, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457065
- Sponsor's protocol ID
- 00028495 D15090
- Status last verified
- Dec 2018
- First submitted
- 27 May 2015
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Care Behaviors Among Melanoma Survivors and Their Families
- ClinicalTrials.gov ID
- NCT02457065
- Acronym / sponsor ID
- 00028495 D15090
- Conditions
- Melanoma
- Keywords
- survivors, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A patient's sun-related behavior greatly influences the likelihood of that patient developing melanoma, the most dangerous form of skin cancer. Prior research shows current educational strategies on inducing preventative behaviors such as wearing sun-protection clothing and wearing sunscreen are inadequate at effectively changing behavior when used in isolation -- patients are aware of the dangers of not engaging in these preventative measures but forgo them nonetheless.
The investigators are researching methods to positively influence skin cancer prevention behaviors among melanoma survivors and their families. The first objective of this study is to compare patient and familial sun exposure and cancer screening activity before and after a patient's diagnosis with primary melanoma. The second objective of this study is to note if hanging a "Melanoma Survivor" plaque in a melanoma survivor's bathroom will significantly affect the survivor's and broader family's sun exposure and cancer screening activity.
The investigators' sample of patients consists of survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and voluntarily chose to participate in the study after being informed of the nature of the research. These patients completed a confidential survey assessing sun exposure related activities immediately before and after their diagnosis. After the participants filled out the survey, the investigators asked the participants if they could nominate a family member to whom the investigators could explain the purpose of this research study to and confidentially ask an additional set of questions to evaluate the broader impact of a melanoma diagnosis. From the investigators' original sample, the investigators randomly chose a few families who would display the survivor plaque in their primary bathroom. After six-to-twelve months, during the each patient's follow up visit, the investigators asked the patient and the patient's nominated family member to fill out another survey to assess sun exposure related activity.
On the surveys, no names were recorded. Everything was anonymous.
Detailed description
This study is investigating a method to positively influence skin cancer prevention behaviors among melanoma survivors and their families. The first objective is to compare patient and familial sun exposure and cancer screening activity before and after a patient's diagnosis with primary cutaneous melanoma less than 4.0 mm in depth. It is believed that the diagnosis will positively affect behavior regarding skin cancer prevention as the diagnosis of melanoma makes the risk associated with sun-exposure and skin cancer a tangible issue. The second objective is to test whether receiving a "Melanoma Survivor" plaque and posting it in a melanoma survivor's bathroom will significantly affect the survivor's and broader family's sun exposure and cancer screening activity. Marketing research has shown similar techniques have been effective in causing individuals to consume goods (e.g. getting free pens with company logos makes you more likely to buy goods from that company), and the investigators think such techniques are transferable into the field of public health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive Plaque | Experimental | Behavioral: "Melanoma Survivor" plaqueTreatment "Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators gave the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors. |
| Do Not Receive Plaque | No intervention | –Control No "Melanoma Survivor" plaque: After the patients enrolled in the study and completed the initial survey, the investigators did not give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors or any other intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient has melanoma diagnosis within past 10 years less than 4mm in depth
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| "Melanoma Survivor" plaqueAlso: Receive PlaqueThe investigators give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors. | Behavioural | Receive Plaque |
Primary outcome
Influence of a Patient's Melanoma Diagnosis on the Survivor's and Broader Family's Skin Cancer Prevention Activity.
Time frame: Collected via a survey administered immediately after a subject enrolled in the study.
Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity before and after the patient's diagnosis with primary melanoma. Subjects self-reported if the diagnosis changed their behavior.
Influence of a "Melanoma Survivor" Plaque on the Survivor's and Broader Family's Skin Cancer Prevention Activity.
Time frame: 6-12 months between time of completion of first survey and second survey.
Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. The investigators randomly gave some subjects a "Melanoma Survivor" plaque. After 6-12 months, the subjects again filled out a survey assessing their skin cancer prevention behaviors. The investigators analyzed the difference in each subject's responses to the same survey questions over time. The investigators then analyzed the difference between the responses of the subjects who saw the plaque and the subjects who did not see the plaque to discern the influence of the plaque on skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity. Subjects self-reported if the their behavior changed over time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael S Chapman, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Melanoma Survivor" plaque in people with Melanoma, run by Dartmouth-Hitchcock Medical 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 1 inclusion and 0 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 Dec 2018. 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 19 Dec 2018). 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?
Influence of a Patient's Melanoma Diagnosis on the Survivor's and Broader Family's Skin Cancer Prevention Activity. (time frame: Collected via a survey administered immediately after a subject enrolled in the study.). The study lists 2 primary outcomes in all. 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 Dec 2018.