Kaposi Sarcoma
Conditions
Keywords
Global Oncology, Kaposi Sarcoma, Affordable Cancer Technologies, Cancer in People with HIV, Human Centered Design, Discrete Choice Experiment, Medical devices, Low-cost design, Global health
Brief summary
AIMS 2 & 3: In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.
Interventions
DEVICESkinScan3D
A handheld, simple, low-cost, and user-friendly technology that combines liquid lens technology and artificial intelligence (AI).
Sponsors
Washington University School of Medicine
National Cancer Institute (NCI)
Pensievision
Kenya Medical Research Institute
Makerere University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Aim 2 (Patients): * Adults age ≥18 years old * Histopathology-confirmed Kaposi Sarcoma * At least 3 skin lesions * Capable of informed consent * On treatment for Kaposi Sarcoma
Exclusion criteria
- Aim 2 (Patients): * Patients not initiating Kaposi Sarcoma treatment * Very ill patients requiring hospitalization Inclusion Criteria - Aim 3 (Patients): * Adults age ≥18 years old * Histopathology-confirmed Kaposi Sarcoma * Capable of informed consent * Initiating treatment for Kaposi Sarcoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only | Approximately 3 months | Reproducibility/agreement between clinicians for each method is measured using the concordance correlation coefficient (CCC). A higher CCC means a more reproducible method. |
| Accuracy of KS lesion size measurements between SkinScan3D and current standard of care measurement - Aim 2 Only | Approximately 3 months | Accuracy is measured using the coefficient of determination (R-squared). The R-squared tells us how much variation is due to varying lesion size as measured by either method versus how much variation is due to random error. When the variation due to random error is small, the R-squared value is closer to 1; when the variation due to random error is large, the R-squared value is farther from 1. |
| Device usability - Aim 3 Only | 6 months | Device usability will be measured using the System Usability Scale. The SUS will result in a single composite score for each individual and the scores will be averaged to result in a single overall usability score. |
| Acceptability - Aim 3 Only | 6 months | Acceptability of Intervention Measure (AIM), present participants with a set of 4 questions regarding their perception of an intervention's acceptability, typically on a 5-point Likert scale (completely disagree to completely agree), then calculate the average score across all items, with higher scores indicating greater perceived acceptability of the intervention. |
| Appropriateness - Aim 3 Only | 6 months | Intervention Appropriateness Measure (IAM), will present a set of four questions to healthcare providers about how well SS3D works in their context. Each item is rated on a Likert scale, with higher scores indicating greater perceived appropriateness. |
| Feasibility - Aim 3 Only | 6 months | FIM (Feasibility of Intervention Measure), will give the four-item questionnaire to healthcare providers asking them to rate how feasible they believe a specific intervention is on a Likert scale, usually ranging from "completely disagree" to "completely agree"; a higher score indicates greater perceived feasibility, with the average score across all items representing the overall feasibility rating of the intervention in that context. |
Countries
Kenya, Uganda
Contacts
CONTACTThomas Odeny, MBChB, MPH, PhD
PRINCIPAL_INVESTIGATORThomas Odeny, MBChB, MPH, PhD
Washington University School of Medicine
Outcome results
None listed