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

March 9, 2021 updated by: June Robinson, Northwestern University

A Comparison of Interventions to Teach Patients Skin Self-examination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The completed R01 demonstrated preliminary evidence for a melanoma survivor and partner skin self-examination (SSE) training program resulting in regular and accurate SSEs relative to patients and partners receiving treatment as usual care. However, one caveat is that the patients and partners in the well-controlled study are potentially being cued to conduct the SSEs following training and reinforced for their actions. Whereas in "real-world" conditions the participants would see their dermatologist less frequently with significantly less cueing to conduct SSEs.

This research addresses this limitation by examining the long-term influence of SSE training on SSE knowledge, self-efficacy, performance, and accuracy under real-world conditions for melanoma patients in the treatment group from the ongoing R01 study relative to controls (Aim 1). In addition, the continuation study will also examine for whom the intervention works best under real-world conditions (Aim 2). Findings from clinical RCTs of behavioral interventions involving patients are rarely if ever, examined to determine generalizability to real-world settings. The current proposal will contribute critical information to the scientific literature on the impact of early detection of melanomas using SSEs and will be the first to test the sustainability and long-term impact of an efficacious SSE intervention for early detection targeting melanoma survivors in real-world settings. Relationship factors to help sustain skin self-examination will also be evaluated.

The amended part of the study is 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. The Shade sensor provided a more reliable time-stamped assessment. With the use of the Daily Minutes of Unprotected Sun Exposure Inventory (MUSE) and the Shade sensors, the investigators assessed the sun protection behaviors of melanoma survivors and found that 13% of the melanoma survivors were surprised by their amount of UV exposure.

The investigators now wish to determine the feasibility of simultaneously obtaining wearable sensor data for physical activity (ActiGraph) and the Shade sensor and completion of self-reported surveys for the same time period. The feasibility and methodological information derived from this project are highly relevant to capture and quantify UV exposure among physically active individuals.

A total of 40 participants will be recruited for this phase (324 from initial study + 40 from amended section = 364 anticipated total).Ten participants (5 melanoma survivors and 5 young adult relatives), testing the feasibility of wearing two sensors and completing daily online surveys. After feasibility testing, the study will enroll melanoma survivors, age 18-70 years, with Stages 0-1A (n=15) and their young adult relatives (n=15) who are 18-39 years old. The sex of enrolled participants will be monitored to assure equivalent numbers of male and female participants.

Two arms were added: a) Feasibility of wearing 2 sensors, and b) Feasibility of completing online daily survey. The research team will strive to integrate event level data in real-time. At the conclusion of the study, participants receive a report of their UV exposure and physical activity over the 7 days of the study. Eligibility Criteria has also been updated for the amended portion of the study.

Distance (remote) learning will be compared with in-person learning with online surveys assessing SSE knowledge, confidence, anxiety and performance. Electronic health record review will identify biopsies of concerning moles and the number and stage of melanomas identified.

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • June K Robinson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria Melanoma survivors

  • 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
  • Willing to participate in daily online assessments
  • Willing 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

Exclusion Criteria

  • Excluded subjects are those 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) and have an ECOG performance status >1 will also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: skin self-examination

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
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)
Other Names:
  • MoleScore
Experimental: Skin Self- examination:Distance (remote) learning
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
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)
Other Names:
  • MoleScore
Active Comparator: Active control

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
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)
Other Names:
  • MoleScore
Placebo Comparator: Assessment-only control

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
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)
Other Names:
  • MoleScore
No Intervention: Observational study 1

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
No Intervention: Observational study 2

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
No Intervention: Relationship Factors Study Observational Study

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*
Active Comparator: Relationship Factors Study- Skin Self Examination

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
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)
Other Names:
  • MoleScore
Active Comparator: Comparison of distance (remote) learning vs in-person learning
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
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)
Other Names:
  • MoleScore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge and Performance of Skin self-examination
Time Frame: 18 months
online survey of validates measures
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Identification of melanoma
Time Frame: 18 months
Biopsy of clinically concerning lesions
18 months
Moderation of SSE performance and accuracy by patient-partner relationship qualities and age
Time Frame: 18 months
online survey
18 months
Relationship factors helping to sustain SSE
Time Frame: 18 months
online survey
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of remote training and In-person training with the workbook
Time Frame: 54 months
online survey and electronic medical record review
54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

March 9, 2021

Study Completion (Actual)

March 9, 2021

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 30, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00201983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publish results

IPD Sharing Time Frame

Deidentified data available 10/2020 for one year

IPD Sharing Access Criteria

Open

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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