- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01432860
A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Population based registries document that survival from melanoma, a growing public health problem with approximately 70,000 new melanoma cases and an estimated 8,600 deaths in 2010, is dependent on the thickness of the melanoma. By facilitating seeking medical care, skin self-examinations (SSEs) by individuals with a prior history of melanoma, who are at risk to develop subsequent melanomas, may lead to the early detection and treatment of melanoma when it is usually more effective. Thus, further research that enhances early detection is warranted and our application directly tests novel methods of training high-risk melanoma patients and their partners on how to conduct SSEs to promote early detection. Our proposed research builds upon the strengths of the R21 that: a) established that in-person training to conduct SSE with a partner significantly enhanced SSE performance 4 months after the intervention, and b) developed and pilot tested a manualized take-home workbook training approach (WORKBOOK). Our pilot work on the WORKBOOK with partners suggests that patient-partner dyads (n = 21) perceived it to be readable, useful, and in the short term 4 month follow-up, empirically equivalent in promoting SSE knowledge, skills, and behaviors compared with patient-partner dyads in the in-person partner training condition (n = 19). Our proposed research builds on our NCI funded studies by conducting a formal examination with 430 pairs (860 subjects) randomized to either the in-person or workbook training vs. an assessment only control group that receives standard of care over a 2 year longitudinal study with 4 month interval evaluations. An additional group of 70 pairs (140 subjects) has been added to test a tablet computer-based program.
Our proposed research directly tests novel methods of training Stage I and IIB melanoma patients, who have a 5 year survival of 80-90%, and their partners, on how to conduct SSEs. We will compare the efficacy of the in-person training vs. workbook for patients and partners vs. controls on SSE knowledge/skill acquisition and retention, and SSE performance and accuracy on a short (4 and 8 months post baseline) and long term basis (12, 16, 20, and 24 months post baseline) and examine whether partner-patient relationship-qualities moderate the relationship between the training approaches and SSEs knowledge/skill acquisition and retention, and SSE performance and accuracy. The tablet computer-based program will also be tested for efficacy and compared with the previous groups.
Establishing health promotion partnerships is important to those at risk to develop melanoma because SSE is difficult to successfully perform as an individual. It is expected that the workbook will promote SSE at least as well as and perhaps better than in-person training and become an easily disseminated SSE training approach that is not dependent on the time and teaching skills of the non-MD clinical office staff.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Department of Dermatology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Personal history of Stage 0 through IIB melanoma
- At least 6 weeks post surgical treatment of Stage 0 through IIA melanoma
- Age 18-80 years old
- Have sufficient vision to read a newspaper in order to visually detect changes on skin
- Able to read English
- Have a partner willing to participate in skin checks
Exclusion Criteria:
1.Subjects overburdened with other co- morbid diseases, medical treatments (e.g. chemotherapy), unable to participate in a conversation at a sixth grade language level due to cognitive impairment (e.g. by a stroke), or prior participation in SSE research.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: In-person Counseling and Education
In the in-person training the Research Assistant demonstrates the use of a mm ruler, a lighted magnifying lens, a set of body maps and a scorecard, 4 pens, ABCDE rule on the skin exam card and discusses the ABCDE rule by pointing to the color examples on the skin exam card.
165 pairs (330 subjects) are randomized to this arm.
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The design is a 3 [in-person training of patients and partners (PARTNER) vs. workbook training of patients and partners (WORKBOOK) vs. an assessment only group that receives education and treatment as usual care] X 7 [baseline, 4, 8, 12, 16, 20, and 24 month follow-up] study.
Standard education of melanoma patients, which are to be performed with the study partner, includes a recommendation to check moles and mark ones to remember on a body map.
All participants receive the same measures and will be recruited using the same procedures, thus, yielding equivalence across conditions.
Pairs will observe how to use their skin check tools and be asked to demonstrate their competence in using them.
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Aktiv komparator: Workbook
The workbook, which includes all of the information delivered in the in-person intervention, is 39 pages in length, and has 76 color figures.
Each element of the in-person training represents a chapter in the workbook.
The introduction explores the partners' understanding of melanoma and their personal risk of developing another melanoma, and attitudes about the benefit of early detection assisted by a partner.
The early detection segment uses a skin diagram to illustrate the difference between thin and thick melanoma and presents the treatment based on the depth of the melanoma.
165 pairs (330 subjects) are randomized to this arm.
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Participants will read a workbook and perform skills training exercises.
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Ingen indgriben: Control
Education and counseling as usually delivered in clinical practice.
100 pairs (200 subjects) are randomized to this arm.
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Aktiv komparator: Tablet Computer-Based Education
Education will be given by an interactive tablet app.
Each pair will view video recordings of certain parts of the in-person presentation as well as select slides from the in-person PowerPoint presentation.
Parts of the workbook will be incorporated as well.
70 pairs (140 subjects) are randomized into this arm.
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Participants will receive their education from an interactive app designed for a tablet computer.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Self-Efficacy in Performing SSE
Tidsramme: 24 months
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To compare the self-efficacy of the in-person training vs. workbook for patients and partners by self-report on a survey at 4-month intervals over 24 months.
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24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Accuracy
Tidsramme: 24 months
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Accurate identification of concerning lesions (melanoma) by participants performing SSE in comparison with the dermatologist's assessment.
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24 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- Turrisi R, Hultgren B, Mallett KA, Martini M, Robinson JK. Comparison of Efficacy of Differing Partner-Assisted Skin Examination Interventions for Melanoma Patients: A Randomized Clinical Trial. JAMA Dermatol. 2015 Sep;151(9):945-51. doi: 10.1001/jamadermatol.2015.0690.
- Rikki G, Brittney H, Jerod S, Mallett Kimberly A, Rob T, Claudia H, Karl B, Wayne Jeffrey D, Martini Mary C, Robinson June K. The Influence of Disease Perceptions on the Participation of Melanoma Patients and their Partners in Skin Self-Examination Education. J Community Med Health Educ. 2013 Nov 1;3(6):242. doi: 10.4172/2161-0711.1000242.
- Gaber R, Mallett KA, Hultgren B, Turrisi R, Gilbertsen ML, Martini MC, Robinson JK. Enhanced fidelity of an educational intervention on skin self-examination through surveillance and standardization. J Nurs Educ Pract. 2014;4(2):253-258. doi: 10.5430/jnep.v4n2p253.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STU17005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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Kliniske forsøg med Melanom
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbAktiv, ikke rekrutterendeMetastatisk uveal melanom | Metastatisk malign neoplasma i leveren | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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