Clinical trial · Interventional
Teaching Skin Self -Examination to Melanoma Patients and Their Skin Check Partners
A Comparison of Interventions to Teach Patients Skin Self-examination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin Self- examination structured training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- skin self-examination
- description
- 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.
- interventionNames
- Behavioral: Skin Self- examination structured training
- type
- EXPERIMENTAL
- label
- Skin Self- examination:Distance (remote) learning
- description
- 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.
- interventionNames
- Behavioral: Skin Self- examination structured training
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDRobinson 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
- BACKGROUNDRobinson 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
- BACKGROUNDRobinson 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
- BACKGROUNDHultgren 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
- BACKGROUNDStapleton 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
- BACKGROUNDRobinson 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.