NCT03564769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

December 6, 2017

Last Update Submit

August 12, 2019

Conditions

Keywords

screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Completion of a physician skin examination

    6 months

  • Patient thorough skin self-examination (TSSE)

    6 months

  • Patient attitude towards sun protection

    6 months

Study Arms (2)

Intervention Arm 1

EXPERIMENTAL

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 ArmOther: AAD SPOTmeⓇ skin cancer screening

Intervention Arm 2

EXPERIMENTAL

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

Interventions

Individuals randomized to the intervention group will receive skin cancer screening educational materials.

Intervention Arm 1

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

Intervention Arm 1Intervention Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alan Geller, MPH, RN

    Harvard TH Chan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPH, RN

Study Record Dates

First Submitted

December 6, 2017

First Posted

June 21, 2018

Study Start

December 1, 2017

Primary Completion

October 1, 2018

Study Completion

June 1, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations