MelanomaPSWNCT02854657
Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
A study testing Skin Self- examination structured training in people with Melanoma, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Skin Self- examination structured training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 682 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 9 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- Skin Self- examination structured training
- Keywords
- melanoma, skin self-examination
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Self- examination structured trainingBehavioural
Also called MoleScore
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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* Receives: 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. Receives: Behavioral: Skin Self- examination structured training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and Performance of Skin self-examination
online survey of validates measures
Measured: 18 months
Secondary outcomes (3)
Accuracy of Identification of melanoma
Biopsy of clinically concerning lesions
Measured: 18 months
Moderation of SSE performance and accuracy by patient-partner relationship qualities and age
online survey
Measured: 18 months
Relationship factors helping to sustain SSE
online survey
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, June Robinson, Northwestern University
- Investigators
- June K Robinson, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854657
- Sponsor's protocol ID
- STU00201983
- Acronym
- PSW
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2016
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: publish results
Publications
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.
PubMed 30773613Robinson 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.
PubMed 27973675Robinson 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.
PubMed 27367303Hultgren 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.
PubMed 26422745Stapleton 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.
PubMed 26063475Robinson 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.
PubMed 24418949Robinson 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.
PubMed 32761987Robinson 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.
PubMed 32292057Robinson 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.
PubMed 32222067Robinson 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.
PubMed 31774148Robinson 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.
PubMed 18258332
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Interventions to Teach Patients Skin Self-examination
- ClinicalTrials.gov ID
- NCT02854657
- Acronym / sponsor ID
- PSW / STU00201983
- Conditions
- Melanoma
- Keywords
- melanoma, skin self-examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| skin self-examination | Experimental | Behavioral: Skin Self- examination structured trainingParticipants 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. |
| Skin Self- examination:Distance (remote) learning | Experimental | Behavioral: Skin Self- examination structured trainingParticipants 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. |
| Active control | Active comparator | Behavioral: Skin Self- examination structured trainingParticipants 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. |
| Assessment-only control | Placebo comparator | Behavioral: Skin Self- examination structured trainingParticipants 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. |
| 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 | Behavioral: Skin Self- examination structured trainingIdentification 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* |
| Comparison of distance (remote) learning vs in-person learning | Active comparator | Behavioral: Skin Self- examination structured trainingControls 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Self- examination structured trainingAlso: MoleScoreA 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) | Behavioural | 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 |
Primary outcome
Knowledge and Performance of Skin self-examination
Time frame: 18 months
online survey of validates measures
3 secondary outcomes
Accuracy of Identification of melanoma
Time frame: 18 months
Moderation of SSE performance and accuracy by patient-partner relationship qualities and age
Time frame: 18 months
Relationship factors helping to sustain SSE
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 30773613Robinson 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.
- Background: PubMed 27973675Robinson 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.
- Background: PubMed 27367303Robinson 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.
- Background: PubMed 26422745Hultgren 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.
- Background: PubMed 26063475Stapleton 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.
- Background: PubMed 24418949Robinson 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.
- Background: PubMed 32761987Robinson 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.
- Background: PubMed 32292057Robinson 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.
- Background: PubMed 32222067Robinson 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.
- Background: PubMed 31774148Robinson 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.
- Results publication: PubMed 18258332Robinson 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.
- Individual participant dataSharing planned: Yes. publish results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June K Robinson, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Self- examination structured training in people with Melanoma, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and Performance of Skin self-examination (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854657, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.