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Trial record 2 of 538 for:    "Skin cancer"

Evaluation Study of SPOTme® Skin Cancer Screenings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03564769
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
American Academy of Dermatology (AAD)
Information provided by (Responsible Party):
Alan Geller, Harvard School of Public Health

Brief Summary:
This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.

Condition or disease Intervention/treatment Phase
Skin Cancer Behavioral: Intervention Arm Other: AAD SPOTmeⓇ skin cancer screening Not Applicable

Detailed Description:

Despite tremendous growth in both the interest and volume of skin cancer screenings at the national level, the actual utility and impact of the AAD SPOT me™ skin cancer screening programs have not been fully evaluated. This study will address this knowledge gap. Early detection is vital in the fight against skin cancer, the most common cancer in the United States. While the effects of skin cancer can be devastating, this disease is highly treatable when detected early.

This study evaluates the impact of the AAD SPOTme® skin cancer screening events on attendees' skin cancer prevention and detection behaviors. This study will also evaluate whether an educational intervention will improve post-screening engagement of attendees with dermatologists.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation Study of SPOTme® Skin Cancer Screenings
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: Intervention Arm 1
Individuals randomized to intervention group 1 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 AND will receive additional skin cancer screening educational materials.
Behavioral: Intervention Arm
Individuals randomized to the intervention group will receive skin cancer screening educational materials.

Other: AAD SPOTmeⓇ skin cancer screening
All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.

Experimental: Intervention Arm 2
Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.
Other: AAD SPOTmeⓇ skin cancer screening
All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.




Primary Outcome Measures :
  1. Completion of a physician skin examination [ Time Frame: Baseline ]
    Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the period following patient's receipt of an AAD SPOTme® skin cancer screening to the baseline assessment.


Secondary Outcome Measures :
  1. Completion of a physician skin examination [ Time Frame: 6 months ]
    Self-report of a physician skin examination will be defined as a health care provider examining the patient's entire body for any sign of skin cancer during the 3 months prior to the 6-month follow up assessment

  2. Patient thorough skin self-examination (TSSE) [ Time Frame: 6 months ]
    Self-report of patient thorough skin self-examination (TSSE) will be defined as performing at least one TSSE during the 3 months prior to the 6-month follow up assessment

  3. Patient attitude towards sun protection [ Time Frame: 6 months ]
    Self-report of patient attitude towards use of sun protection will be defined by likelihood of engaging in sun protection practices in the year following the 6-month follow up assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated in the American Academy of Dermatology national screening program in 2016 or 2017
  • Have a presumptive diagnosis (screening, non-confirmed) of melanoma
  • Have provided the AAD with permission to be re-contacted
  • Have provided the AAD with an email address
  • Aged 18 years or older
  • Able to read English

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564769


Locations
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United States, Massachusetts
Harvard TH Chan School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
American Academy of Dermatology (AAD)
Investigators
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Principal Investigator: Alan Geller, MPH, RN Harvard TH Chan School of Public Health

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Responsible Party: Alan Geller, MPH, RN, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT03564769     History of Changes
Other Study ID Numbers: 17-1668
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alan Geller, Harvard School of Public Health:
screening

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases