Skin Self-Examination Education During Mammography

NCT03512457 | Completed Results

• 1 other identifier: STU00207179
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The skin self-examination for melanoma (SSE) educational materials were developed with the input provided by women undergoing screening mammograms. The investigators seek to evaluate the performance of SSE by women and find out if women seek care with a dermatologist for a concerning mole or for a melanoma screening examination by a dermatologist after reviewing the materials received during the mammogram visit. The purpose of this study is to enhance the early detection of melanoma among women who are engaging in health promotion by having mammograms. The investigators specifically aim to evaluate the performance of SSE by women, who receive information during their mammogram appointment, and then follow-up with dermatology for a melanoma screening examination.

Conditions

Melanoma

Keywords

Melanoma; Skin self-examination; mammogram

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Performed a Skin Self-Examination at 3-months

  The percentage of participants that performed skin self-examination at the 3-month time interval.

  3-months

Secondary Outcomes (1)

• Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion

  7-months

Study Arms (2)

Intensive Intervention

EXPERIMENTAL

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Behavioral: Intensive Intervention

Minimal Intervention

ACTIVE COMPARATOR

Participants receive brochure, card advising how to make an appointment with dermatology, and reminder in one week to perform SSE.

Behavioral: Minimal Intervention

Interventions

Minimal Intervention BEHAVIORAL

Women view an educational poster in changing room, and they receive a brochure.

Minimal Intervention

Intensive Intervention BEHAVIORAL

Women view an educational poster in changing room, and they receive a brochure.

Intensive Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women waiting to have a mammogram
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years of age or older
• Waiting to have a mammogram

You may not qualify if:

• Male

Sponsors & Collaborators

• Northwestern University: lead
• Sarah M. Friedewald, MD: collaborator
• Jennifer N. Choi, MD: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Rzepecki AK, Jain N, Ali Y, Chavez L, Choi J, Schlosser B, Liko-Hazizi E, Friedewald SM, Robinson JK. Promoting early detection of melanoma during the mammography experience. Int J Womens Dermatol. 2017 Jul 5;3(4):195-200. doi: 10.1016/j.ijwd.2017.06.002. eCollection 2017 Dec.

  PMID: 29234713 RESULT

• Robinson JK, Perez M, Abou-El-Seoud D, Kim K, Brown Z, Liko-Hazizi E, Friedewald SM, Kwasny M, Spring B. Targeted Melanoma Screening: Risk Self-Assessment and Skin Self-Examination Education Delivered During Mammography of Women. JNCI Cancer Spectr. 2019 Jun 28;3(3):pkz047. doi: 10.1093/jncics/pkz047. eCollection 2019 Sep.

  PMID: 32328556 RESULT

• Robinson JK, Brown Z, Spring B. Melanoma Skin Self-Examination Education During Mammography: Health Burden of Women Impairs Implementation. J Cancer Educ. 2021 Aug;36(4):858-864. doi: 10.1007/s13187-020-01714-4.

  PMID: 32090289 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Limitations of our study include a relatively short duration of follow-up resulting in a modest number of incident invasive melanoma cases and a lack of participant blinding of allocation to intervention arms.

Results Point of Contact

• Title: Dr. June Robinson
• Organization: Northwestern University

june-robinson@northwestern.edu

312-503-5941

Study Officials

• June K. Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: study arm not disclosed
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Dermatology

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 30, 2018
• Study Start: May 30, 2018
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: April 13, 2021
• Results First Posted: February 5, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)