Skip to content

A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

A Comparison of Interventions to Teach Melanoma Patients Skin Self-examination

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01432860
Enrollment
1000
Registered
2011-09-13
Start date
2011-09-30
Completion date
2015-05-31
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Skin Self Examination

Brief summary

The almost 724,000 Americans survivors of melanoma are estimated to have 4 first degree relatives per case; thus, 2.8 million Americans are at increased risk of developing melanoma in comparison to the general public. Skin self-examination (SSE) with the assistance of a partner by these individuals could improve survival. If effective, the workbook tested in this proposal could be distributed to people at risk of developing melanoma by large scale means in physicians office.

Detailed description

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.

Interventions

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.

BEHAVIORALWorkbook

Participants will read a workbook and perform skills training exercises.

BEHAVIORALTablet Computer-Based Education

Participants will receive their education from an interactive app designed for a tablet computer.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Personal history of Stage 0 through IIB melanoma 2. At least 6 weeks post surgical treatment of Stage 0 through IIA melanoma 3. Age 18-80 years old 4. Have sufficient vision to read a newspaper in order to visually detect changes on skin 5. Able to read English 6. 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.

Design outcomes

Primary

MeasureTime frameDescription
Self-Efficacy in Performing SSE24 monthsTo 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.

Secondary

MeasureTime frameDescription
Accuracy24 monthsAccurate identification of concerning lesions (melanoma) by participants performing SSE in comparison with the dermatologist's assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026