NCT04799106

Brief Summary

The purpose of this study is to pilot the use of community education and digital dermatology to increase the early detection of curable melanomas.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2.8 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

March 9, 2021

Last Update Submit

August 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Completion of self and partner skin examinations

    Proportion of individuals recruited to those that follow through with the protocol

    3 months

  • Completion of self and partner skin examinations

    Proportion of individuals recruited to those that follow through with the protocol

    6 months

Interventions

The main procedures of this study include educational sessions about melanoma and how to detect it at its earliest stages with the help of a community health worker, conducting a self-skin examination every three months, helping to perform a skin examination every three months for a family member or friend who would be selected as a "partner", and completing short questionnaires at the beginning of the study, at month three during the study, and at completion of the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200 melanoma survivors drawn from the California Cancer Registry will be invited to participate in the study. Assuming a 20% response rate, approximately 40 individuals will be identified to participate in the study, including 20 in Southern California and 20 in Northern California. Participants will be invited to identify up to four friends or first-degree family members to also participate in the study, for a total of 200 participants.

You may qualify if:

  • years and older
  • \>1mm lesion thickness with ulceration (T2b) or \>2mm lesion thickness (T3/T4)
  • Low socioeconomic status (SES) Non-Latinx White individuals (according to Yost's index SES level based on a principal components analysis)
  • Latinx individuals
  • Individual resides in semi-rural area, including zip codes within Antelope Valley in Southern California and Salinas in Northern California
  • Individual speaks and reads English or Spanish
  • Voluntary willingness and comprehension to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Haile, DrPH, MPH

    Cedars-Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayden Hutchison, MSW, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cancer Research Center for Health Equity

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 16, 2021

Study Start

January 1, 2024

Primary Completion

January 31, 2025

Study Completion

March 1, 2025

Last Updated

August 29, 2023

Record last verified: 2023-08