Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners

NCT02854657 | Completed DMC

• 1 other identifier: STU00201983
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a continuation of a research program (STU00017005: Interventions to teach melanoma patients skin self-examination) designed to increase early detection of melanomas before they metastasize. In 2015, approximately 73,870 individuals in the U.S. will be diagnosed with invasive melanoma and about 9,940 will die from the disease. During 2002-2011, melanoma incidence increased at an average annual rate of 1.6% for men and 1.5% for women. People with a history of melanoma have a 10 times greater risk of developing a second primary melanoma relative to the general population. Early detection with surgical excision at an earlier stage when treatment is usually more effective is the only proven curative strategy. Relationship factors to help sustain skin self-examination will also be evaluated. The study has been amended to include an administrative supplement, which builds upon the pilot research completed during the summer of 2017 that measured the efficacy of two wearable UV sensors (Shade and Wearifi) and a survey assessing sun protection along with the quality of life. See Detailed Description for a description of amendment addition. This research was expanded to distance (remote) learning provided by mailing the same workbook used in the in-office training.

Conditions

Melanoma

Keywords

melanoma; skin self-examination

Outcome Measures

Primary Outcomes (1)

• Knowledge and Performance of Skin self-examination

  online survey of validates measures

  18 months

Secondary Outcomes (3)

• Accuracy of Identification of melanoma

  18 months

• Moderation of SSE performance and accuracy by patient-partner relationship qualities and age

  18 months

• Relationship factors helping to sustain SSE

  18 months

Other Outcomes (1)

• Comparison of remote training and In-person training with the workbook

  54 months

Study Arms (9)

skin self-examination

EXPERIMENTAL

Participants from the treatment arms of the original RCT. It is anticipated that 228 participant dyads that are 18-70 years old from the original study will be invited to continue in the ongoing study. These subjects received Skin Self- examination structured training. The subject are being followed for an additional period of time after receiving an educational intervention.

Behavioral: Skin Self- examination structured training

Skin Self- examination:Distance (remote) learning

EXPERIMENTAL

Participants receive the Skin Self- examination structured training with partner assistance educational intervention via mailed workbook while under the customary care of their own dermatologists. It is anticipated that 50 new participant dyads will be recruited and randomized to this group.

Behavioral: Skin Self- examination structured training

Active control

ACTIVE COMPARATOR

Participants from the control arm of the original RCT. It is anticipated that 100 participant dyads that are 18-70 years old from the original study will be invited to continue in the ongoing study. These subjects are controls and do not receive the structured training in skin self-examination with partner assistance at the beginning of the study. After completing the 18 month online survey, the subjects may request the Skin Self- examination structured training with partner assistance.

Behavioral: Skin Self- examination structured training

Assessment-only control

PLACEBO COMPARATOR

Participants who receive customary care from their own dermatologists. It is anticipated that 150 new participant dyads will be recruited and randomized to this group. These subjects are controls and do not receive the structured training in skin self-examination with partner assistance at the beginning of the study. After completing the 18 month online survey, the subjects may request the structured training in skin self-examination with partner assistance.

Behavioral: Skin Self- examination structured training

Observational study 1

NO INTERVENTION

Feasibility of wearing 2 sensors No intervention. At the conclusion of the study, participants receive a report of their UV exposure and physical activity over the 7 days of the study. N= 10

Observational study 2

NO INTERVENTION

Feasibility of completing online daily survey. The research team will strive to integrate event level data in real -time No intervention. At the conclusion of the study, participants receive an event level reports of their daily UV exposure and physical activity over the 7 days of the study. N= 30

Relationship Factors Study Observational Study

NO INTERVENTION

Identification of how shared responsibility for SSE (i.e., "being in this together) contributed to SSE frequency and provide dermatologists with practical information they can efficiently communicate to patients with a history of melanoma to increase SSE. No intervention- Control group. n=144 Results pending\*

Relationship Factors Study- Skin Self Examination

ACTIVE COMPARATOR

Identification of how shared responsibility for SSE (i.e., "being in this together) contributed to SSE frequency and provide dermatologists with practical information they can efficiently communicate to patients with a history of melanoma to increase SSE. Intervention= Skin self-examination training n=197 Results Pending\*

Behavioral: Skin Self- examination structured training

Comparison of distance (remote) learning vs in-person learning

ACTIVE COMPARATOR

Controls re-enrolled from the original study (n=38) and newly enrolled in the distance (remote) learning (n=106) are compared with participants receiving the workbook in-person in the original study and re-enrolled (n=134) and participants newly enrolled in distance (remote) learning, who had the workbook mailed to them (n=63). Online surveys assessed SSE knowledge, confidence, anxiety and performance. Electronic health record review identified biopsies of concerning moles and the number of melanomas identified.

Behavioral: Skin Self- examination structured training

Interventions

Skin Self- examination structured training BEHAVIORAL

A PowerPoint presentation will be provided as a PDF file. The file will be available in English and Spanish. This is the same skin self-examination structured training intervention used in the original RCT (MoleScore)

Also known as: MoleScore

Active control; Assessment-only control; Comparison of distance (remote) learning vs in-person learning; Relationship Factors Study- Skin Self Examination; Skin Self- examination:Distance (remote) learning; skin self-examination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Personal history of Stage 0 (in situ) to IIB melanoma
• At least 6 weeks post-surgical treatment of Stage 0 (in situ) to IIB melanoma
• Age 18-70 years old
• Have sufficient vision to read a newspaper in order to visually detect changes of the skin
• Able to read English or Spanish at a sixth grade language level
• Have a skin check partner (i.e. spouse, family member, or friend) who is willing to participate in the research with the patient

You may not qualify if:

• Subjects overburdened with other co-morbid diseases (e.g. chronic immunosuppression from organ transplantation) or medical treatments (e.g. chemotherapy)
• Subjects unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke)
• For newly enrolled subjects only: Prior participation in skin self-examination research
• Eligibility Criteria for amended portion of the study:
• Ages 18-70, who are participating in the research supported by the R01
• Able to read English at a sixth-grade language level
• Willing to participate in daily online assessments
• Willingness to wear two sensors for 7 consecutive days
• Own a smartphone and able to use a mobile application
• Reliable access to the Internet
• Reliable mailing address for safe delivery and return of sensors
• Capable of walking a quarter of a mile (about 3 city blocks) with little to no difficulty
• Young adult relatives of melanoma survivors
• Ages 18-39 years old
• Able to read English at a sixth-grade language level

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

June K Robinson

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote partner assisted skin self-examination skills training of melanoma survivors and their partners. Australas J Dermatol. 2019 Feb;60(1):e80-e82. doi: 10.1111/ajd.12877. Epub 2018 Jul 10. No abstract available.

  PMID: 30773613 BACKGROUND

• Robinson JK, Hultgren B, Mallett K, Turrisi R. Self-confidence and Embarrassment About Partner-Assisted Skin Self-examination for Melanoma. JAMA Dermatol. 2017 Mar 1;153(3):342-344. doi: 10.1001/jamadermatol.2016.4776. No abstract available.

  PMID: 27973675 BACKGROUND

• Robinson JK, Wayne JD, Martini MC, Hultgren BA, Mallett KA, Turrisi R. Early Detection of New Melanomas by Patients With Melanoma and Their Partners Using a Structured Skin Self-examination Skills Training Intervention: A Randomized Clinical Trial. JAMA Dermatol. 2016 Sep 1;152(9):979-85. doi: 10.1001/jamadermatol.2016.1985.

  PMID: 27367303 BACKGROUND

• Hultgren BA, Turrisi R, Mallett KA, Ackerman S, Robinson JK. Influence of Quality of Relationship Between Patient With Melanoma and Partner on Partner-Assisted Skin Examination Education: A Randomized Clinical Trial. JAMA Dermatol. 2016 Feb;152(2):184-90. doi: 10.1001/jamadermatol.2015.2819.

  PMID: 26422745 BACKGROUND

• Stapleton JL, Turrisi R, Mallett KA, Robinson JK. Correspondence between pigmented lesions identified by melanoma patients trained to perform partner-assisted skin self-examination and dermatological examination. Cancer Epidemiol Biomarkers Prev. 2015 Aug;24(8):1247-53. doi: 10.1158/1055-9965.EPI-15-0218. Epub 2015 Jun 10.

  PMID: 26063475 BACKGROUND

• Robinson JK, Gaber R, Hultgren B, Eilers S, Blatt H, Stapleton J, Mallett K, Turrisi R, Duffecy J, Begale M, Martini M, Bilimoria K, Wayne J. Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions. J Med Internet Res. 2014 Jan 13;16(1):e7. doi: 10.2196/jmir.2883.

  PMID: 24418949 BACKGROUND

• Robinson JK, Reavy R, Mallett KA, Turrisi R. Remote skin self-examination training of melanoma survivors and their skin check partners: A randomized trial and comparison with in-person training. Cancer Med. 2020 Oct;9(19):7301-7309. doi: 10.1002/cam4.3299. Epub 2020 Aug 6.

  PMID: 32761987 BACKGROUND

• Robinson JK. Skin check partner assistance for melanoma skin self-examination by at-risk patients: it takes two to identify melanomas. Future Oncol. 2020 Jun;16(16):1065-1068. doi: 10.2217/fon-2020-0265. Epub 2020 Apr 15. No abstract available.

  PMID: 32292057 BACKGROUND

• Robinson JK, Abou-El-Seoud D, Reavy R, Turrisi R, Mallett KA. Persistence of partner-assisted skin self-examination supported by 'being in this together': a randomized trial. Br J Dermatol. 2020 Sep;183(3):571-573. doi: 10.1111/bjd.19048. Epub 2020 Apr 23. No abstract available.

  PMID: 32222067 BACKGROUND

• Robinson JK. Frequency of 'regular' skin checks by dermatologists for melanoma survivors. Br J Dermatol. 2020 May;182(5):1081. doi: 10.1111/bjd.18626. Epub 2019 Nov 27. No abstract available.

  PMID: 31774148 BACKGROUND

• Robinson JK, Stapleton J, Turrisi R. Relationship and partner moderator variables increase self-efficacy of performing skin self-examination. J Am Acad Dermatol. 2008 May;58(5):755-62. doi: 10.1016/j.jaad.2007.12.027. Epub 2008 Feb 6.

  PMID: 18258332 RESULT

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

Study Officials

• June K Robinson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: August 3, 2016
• Study Start: May 1, 2016
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Deidentified data available 10/2020 for one year
• Access Criteria: Open

Locations

US (1)