Evaluation Study of SPOTme® Skin Cancer Screenings

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.

Study Overview

• Status: Completed
• Conditions: Skin Cancer
• Intervention / Treatment: Behavioral: Intervention Arm; Other: AAD SPOTmeⓇ skin cancer screening

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.

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard TH Chan School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Collaborators: American Academy of Dermatology (AAD)
• Investigators: Principal Investigator: Alan Geller, MPH, RN, Harvard TH Chan School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 17-1668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No