Skin CancerNCT04534868
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
A study testing taking macroscopic and dermoscopic pictures of suspicious skin lesions in people with Skin Cancer and Patient Acceptance of Health Care, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Patient Acceptance of Health Care, Patient Satisfaction
- What is being tested?
- taking macroscopic and dermoscopic pictures of suspicious skin lesions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ( > 18y)
- French Speaking Patient
Who cannot join
- Illiterate Patients
- Demented Patients
- Non-French speaking patients
- Minors.
Trial locations and contacts
No sites are listed yet.
Isabelle Tromme, Dr contact
About this study
Official title: Evaluation of Patients Acceptance and Satisfaction With Teledermoscopy at the General Practionner's Office for the Detection of Skin Cancer in a Rural Area.
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").
- Being tested
- taking macroscopic and dermoscopic pictures of suspicious skin lesions
- Keywords
- Skin Cancer Screening, General Practice, Teledermoscopy, Patient Satisfaction and Acceptance
- Medical subject headings
- Skin Neoplasms, Patient Acceptance of Health Care, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taking macroscopic and dermoscopic pictures of suspicious skin lesionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: taking macroscopic and dermoscopic pictures of suspicious skin lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 15 to 20 minutes (interview duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534868
- Sponsor's protocol ID
- CE 2020/06AOU/397
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27182461Kips 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.
PubMed 30618351Tan 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.
PubMed 20222920Borve 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.
PubMed 24923283van 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.
PubMed 31438348Vestergaard 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.
PubMed 32347299Koh 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.
PubMed 30404081Kong 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.
PubMed 32126557Snoswell 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.
PubMed 30343653Hue 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.
PubMed 26568080Damsin 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.
PubMed 31833275Gilling 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.
PubMed 32179927Mounessa 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.
PubMed 28350281Kruse 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.
PubMed 28775188
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients Acceptance and Satisfaction With Teledermoscopy at the General Practionner's Office for the Detection of Skin Cancer in a Rural Area.
- ClinicalTrials.gov ID
- NCT04534868
- Acronym / sponsor ID
- CE 2020/06AOU/397
- Keywords
- Skin Cancer Screening, General Practice, Teledermoscopy, Patient Satisfaction and Acceptance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Acceptance and satisfaction for teledermoscopy | Other | Other: taking macroscopic and dermoscopic pictures of suspicious skin lesionsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ( > 18y)
- French Speaking Patient
Key exclusion criteria (4 listed)
- Illiterate Patients
- Demented Patients
- Non-French speaking patients
- Minors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taking macroscopic and dermoscopic pictures of suspicious skin lesionsIf 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 | Other | Patient Acceptance and satisfaction for teledermoscopy |
Primary outcome
Patient Acceptability Of Teledermoscopy
Time frame: 20 to 30 minutes to complete the questionnaire.
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)
Patient Satisfaction after a teledermoscopy experience
Time frame: 15 to 20 minutes (interview duration)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Background: PubMed 27182461Tensen 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.
- Background: PubMed 30618351Kips 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.
- Background: PubMed 20222920Tan 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.
- Background: PubMed 24923283Borve 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.
- Background: PubMed 31438348van 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.
- Background: PubMed 32347299Vestergaard 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.
- Background: PubMed 30404081Koh 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.
- Background: PubMed 32126557Kong 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.
- Background: PubMed 30343653Snoswell 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.
- Background: PubMed 26568080Hue 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.
- Background: PubMed 31833275Damsin 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.
- Background: PubMed 32179927Gilling 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Tromme, Dr contact
Questions about this trial
What is this clinical trial studying?
A study testing taking macroscopic and dermoscopic pictures of suspicious skin lesions in people with Skin Cancer and Patient Acceptance of Health Care, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odile MAGOTTEAUX, Dr (0479177991, odile.magotteaux@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Acceptability Of Teledermoscopy (time frame: 20 to 30 minutes to complete the questionnaire.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534868, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.