Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/9/2018 |
| Start Date: | May 2016 |
| End Date: | April 2020 |
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 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.
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 description of amendment addition.
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 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.
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 description of amendment addition.
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.
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.
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.
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.
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.
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Chicago, Illinois 60611
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