Clinical trial NCT02854657: Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
Official title: A Comparison of Interventions to Teach Patients Skin Self-examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Keywords: melanoma
skin self-examination
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge and Performance of Skin self-examination
timeFrame: 18 months
Secondary outcomes:
measure: Accuracy of Identification of melanoma
timeFrame: 18 months
measure: Moderation of SSE performance and accuracy by patient-partner relationship qualities and age
timeFrame: 18 months
measure: Relationship factors helping to sustain SSE
timeFrame: 18 months
Other outcomes:
measure: Comparison of remote training and In-person training with the workbook
timeFrame: 54 months
Locations:
city: Chicago
country: United States
facility: June K Robinson
state: Illinois
Study officials:
affiliation: Northwestern University
name: June K Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.