NCT04534868

Brief Summary

The aim objective of this work is to assess the characteristics of patients for whom teledermoscopy could be suitable for the detection of potential skin cancers, within a population of rural general medicine in the South of Hainaut, by means of a mixed quantitative and qualitative study corresponding respectively:

  • To identify patients' knowledge of skin cancers, their skin monitoring habits, and their acceptability of new telemedicine tools such as teledermoscopy ("Part 1").
  • To evaluate the satisfaction and expectations of those who benefit from teledermoscopy ("Part 2").

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 17, 2020

Last Update Submit

August 27, 2020

Conditions

Keywords

Skin Cancer ScreeningGeneral PracticeTeledermoscopyPatient Satisfaction and Acceptance

Outcome Measures

Primary Outcomes (2)

  • Patient Acceptability Of Teledermoscopy

    Using a quantitative survey-type questionnaire * Determination of the patients ' skin monitoring habits * Determination of patients' knowledge of skin cancers and their prevention * Determine their acceptance of new technologies such as teledermoscopy in the context of skin cancer screening * And finally, determination of a target population for whom teledermoscopy could be suitable for the detection of skin cancers (percentage of patients accepting teledermoscopy etc)

    20 to 30 minutes to complete the questionnaire.

  • Patient Satisfaction after a teledermoscopy experience

    Assessment of the satisfaction and future expectations of patients who have benefited from teledermoscopy in general practice, using a qualitative study in the form of semi-structured, individual and anonymous interviews

    15 to 20 minutes (interview duration)

Study Arms (1)

Patient Acceptance and satisfaction for teledermoscopy

OTHER

The aim of the first part of the study is to evaluate patients' skin monitoring habits, their knowledge of skin cancer, and their preconceptions about new telemedicine tools such as teledermoscopy. This is a written quantitative questionnaire with answers to tick. An explanatory folder will be given to patients and they will be asked to read it beforehand in order to allow a good understanding of the terms used and the goal of the project. This part will include 70 to 100 patients. The second part of the study is a qualitative study and the aim of it is to evaluate the satisfaction, acceptance and future expectations of those who have benefited from teledermoscopy. Individual and anonymous interviews, lasting 15 to 20 minutes, intended for patients who have benefit of teledermoscopy at the office. An explanatory folder will also be given to the patients concerned in order to explain to them the procedure of the interview. This part will include 8 to 10 patients.

Other: taking macroscopic and dermoscopic pictures of suspicious skin lesions

Interventions

If there is any diagnostic doubt about a skin lesion, teledermoscopy will be used, if the patient agrees. * A table containing the useful information about the patient for the lesion's analysis will be completed. * The pictures will be taken with a Fotofinder Handyscope. The photos will be integrated into the patient's electronic medical record (CareConnect program). * The photo is anonymized via a serial number assigned by the "Handyscope" application. * Sending photos and information via a secure email address to the dermatologists. * Response from the dermatologist (Prof. Tromme or Dr Harkemanne) in the following days also via email. * Contact (consultation or telephone call depending on the diagnosis) with the patient to communicate the results and the procedure to be followed. * This information (emails containing the dermatological report) will be saved in the patient's computerized medical file (CareConnect program) then deleted from the mailbox

Patient Acceptance and satisfaction for teledermoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ( \> 18y)
  • French Speaking Patient

You may not qualify if:

  • Illiterate Patients
  • Demented Patients
  • Non-French speaking patients
  • Minors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Tensen E, van der Heijden JP, Jaspers MW, Witkamp L. Two Decades of Teledermatology: Current Status and Integration in National Healthcare Systems. Curr Dermatol Rep. 2016;5:96-104. doi: 10.1007/s13671-016-0136-7. Epub 2016 Mar 28.

    PMID: 27182461BACKGROUND
  • Kips J, Lambert J, Ongenae K, De Sutter A, Verhaeghe E. Teledermatology in Belgium: a pilot study. Acta Clin Belg. 2020 Apr;75(2):116-122. doi: 10.1080/17843286.2018.1561812. Epub 2019 Jan 8.

    PMID: 30618351BACKGROUND
  • Tan E, Yung A, Jameson M, Oakley A, Rademaker M. Successful triage of patients referred to a skin lesion clinic using teledermoscopy (IMAGE IT trial). Br J Dermatol. 2010 Apr;162(4):803-11. doi: 10.1111/j.1365-2133.2010.09673.x. Epub 2010 Mar 5.

    PMID: 20222920BACKGROUND
  • Borve A, Dahlen Gyllencreutz J, Terstappen K, Johansson Backman E, Aldenbratt A, Danielsson M, Gillstedt M, Sandberg C, Paoli J. Smartphone teledermoscopy referrals: a novel process for improved triage of skin cancer patients. Acta Derm Venereol. 2015 Feb;95(2):186-90. doi: 10.2340/00015555-1906.

    PMID: 24923283BACKGROUND
  • van Sinderen F, Tensen E, van der Heijden JP, Witkamp L, Jaspers MWM, Peute LWP. Is Teledermoscopy Improving General Practitioner Skin Cancer Care? Stud Health Technol Inform. 2019 Aug 21;264:1795-1796. doi: 10.3233/SHTI190652.

    PMID: 31438348BACKGROUND
  • Vestergaard T, Prasad SC, Schuster A, Laurinaviciene R, Bygum A, Munck A, Andersen MK. Introducing teledermoscopy of possible skin cancers in general practice in Southern Denmark. Fam Pract. 2020 Sep 5;37(4):513-518. doi: 10.1093/fampra/cmaa041.

    PMID: 32347299BACKGROUND
  • Koh U, Horsham C, Soyer HP, Loescher LJ, Gillespie N, Vagenas D, Janda M. Consumer Acceptance and Expectations of a Mobile Health Application to Photograph Skin Lesions for Early Detection of Melanoma. Dermatology. 2019;235(1):4-10. doi: 10.1159/000493728. Epub 2018 Nov 7.

    PMID: 30404081BACKGROUND
  • Kong F, Horsham C, Rayner J, Simunovic M, O'Hara M, Soyer HP, Janda M. Consumer Preferences for Skin Cancer Screening Using Mobile Teledermoscopy: A Qualitative Study. Dermatology. 2020;236(2):97-104. doi: 10.1159/000505620. Epub 2020 Mar 3.

    PMID: 32126557BACKGROUND
  • Snoswell CL, Whitty JA, Caffery LJ, Loescher LJ, Gillespie N, Janda M. Direct-to-consumer mobile teledermoscopy for skin cancer screening: Preliminary results demonstrating willingness-to-pay in Australia. J Telemed Telecare. 2018 Dec;24(10):683-689. doi: 10.1177/1357633X18799582.

    PMID: 30343653BACKGROUND
  • Hue L, Makhloufi S, Sall N'Diaye P, Blanchet-Bardon C, Sulimovic L, Pomykala F, Colomb M, Baccard M, Lassau F, Reuter G, Keller F, Fite C, Triller R, Cremieux AC. Real-time mobile teledermoscopy for skin cancer screening targeting an agricultural population: an experiment on 289 patients in France. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):20-4. doi: 10.1111/jdv.13404. Epub 2015 Nov 16.

    PMID: 26568080BACKGROUND
  • Damsin T, Jacquemin P, Canivet G, Giet D, Gillet P, Nikkels AF. [TeleSPOT Project : early detection of melanoma by teledermoscopy in general practice]. Rev Med Liege. 2019 Dec;74(12):650-654. French.

    PMID: 31833275BACKGROUND
  • Gilling S, Mortz CG, Vestergaard T. Patient Satisfaction and Expectations Regarding Mobile Teledermoscopy in General Practice for Diagnosis of Non-melanoma Skin Cancer and Malignant Melanoma. Acta Derm Venereol. 2020 Apr 21;100(8):adv00117. doi: 10.2340/00015555-3459.

    PMID: 32179927BACKGROUND
  • Mounessa JS, Chapman S, Braunberger T, Qin R, Lipoff JB, Dellavalle RP, Dunnick CA. A systematic review of satisfaction with teledermatology. J Telemed Telecare. 2018 May;24(4):263-270. doi: 10.1177/1357633X17696587. Epub 2017 Mar 28.

    PMID: 28350281BACKGROUND
  • Kruse CS, Krowski N, Rodriguez B, Tran L, Vela J, Brooks M. Telehealth and patient satisfaction: a systematic review and narrative analysis. BMJ Open. 2017 Aug 3;7(8):e016242. doi: 10.1136/bmjopen-2017-016242.

    PMID: 28775188BACKGROUND

Related Links

MeSH Terms

Conditions

Skin NeoplasmsPatient Acceptance of Health CarePatient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Odile MAGOTTEAUX, Dr

CONTACT

Isabelle Tromme, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2020

First Posted

September 1, 2020

Study Start

September 15, 2020

Primary Completion

February 15, 2021

Study Completion

March 15, 2021

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share