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Evaluation Study of SPOTme® Skin Cancer Screenings

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Arm
AAD SPOTmeⓇ skin cancer screening
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Cancer focused on measuring screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard TH Chan School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Arm 1

Intervention Arm 2

Arm Description

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.

Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.

Outcomes

Primary Outcome Measures

Completion of a physician skin examination
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

Completion of a physician skin examination
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
Patient thorough skin self-examination (TSSE)
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
Patient attitude towards sun protection
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

Full Information

First Posted
December 6, 2017
Last Updated
August 12, 2019
Sponsor
Harvard School of Public Health (HSPH)
Collaborators
American Academy of Dermatology (AAD)
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1. Study Identification

Unique Protocol Identification Number
NCT03564769
Brief Title
Evaluation Study of SPOTme® Skin Cancer Screenings
Official Title
Evaluation Study of SPOTme® Skin Cancer Screenings
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard School of Public Health (HSPH)
Collaborators
American Academy of Dermatology (AAD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Arm 2
Arm Type
Experimental
Arm Description
Individuals randomized to intervention group 2 will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017 only.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Arm
Intervention Description
Individuals randomized to the intervention group will receive skin cancer screening educational materials.
Intervention Type
Other
Intervention Name(s)
AAD SPOTmeⓇ skin cancer screening
Intervention Description
All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.
Primary Outcome Measure Information:
Title
Completion of a physician skin examination
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Completion of a physician skin examination
Description
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
Time Frame
6 months
Title
Patient thorough skin self-examination (TSSE)
Description
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
Time Frame
6 months
Title
Patient attitude towards sun protection
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Geller, MPH, RN
Organizational Affiliation
Harvard TH Chan School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard TH Chan School of Public Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation Study of SPOTme® Skin Cancer Screenings

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