- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03328247
Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma (ASICA)
27 aprile 2021 aggiornato da: University of Aberdeen
Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma: A Randomized Patient-focused Trial of Delivering the ASICA Intervention as a Means to Earlier Detection of Recurrent and Second Primary Melanoma
The ASICA study is looking at how the UK National Health Service (NHS) might use technology in the future to more effectively support people who have been treated for melanoma.
Panoramica dello studio
Descrizione dettagliata
All patients who have been treated for melanoma are advised to regularly examine their own skin (total-skin-self-examinations; TSSE) but research has found that many people are not shown how to do this effectively.
We are investigating whether a digital app we have developed (ASICA) can help people with melanoma to use a hand-held tablet computer to do more regular and effective TSSE, and whether this would lead to earlier detection of recurrent and new primary melanomas.
The ASICA app also uses the internet to enable people to electronically communicate the findings of their TSSE to a specialist nurse.
All those who consent to take part in the study will be randomly allocated into one of two groups.
One group will use the ASICA app in addition to their normal follow-up, the other group will continue to attend their routine melanoma follow-up only.
Participants will be recruited from two UK sites - NHS Grampian and Cambridge University Hospitals.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
240
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Aberdeen, Regno Unito
- University of Aberdeen
-
Cambridge, Regno Unito
- Addenbrookes Hospital
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adult (≥18)
- Patients treated for stage 0-2C cutaneous melanoma within the preceding 24 months
Exclusion Criteria:
- Stage 3 and 4 melanoma.
- Previous local recurrence of melanoma within last 24 months.
- Patients who are unable to consent and/or complete questionnaires (e.g. due to cognitive or language issues).
- Patients who are blind or visually impaired.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Control
Control group will attend their routine melanoma follow-ups
|
|
Sperimentale: Intervention
The intervention group will use the ASICA app in addition to their routine follow-ups
|
Participants in the intervention arm will be trained to use ASICA (in addition to completing routine follow-up) and participants within the control arm will continue to attend their usual structured melanoma follow-up only.
The hypothesis is that the ASICA intervention will increase TSSE practice in those affected by melanoma without affecting psychological well-being and lead to earlier detection of recurrent and new primary melanoma.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The impact of receiving ASICA on cancer worry
Lasso di tempo: Up to 12 months following randomisation.
|
This outcome will be measured using Melanoma Worry Scale (MWS).
The scale consists of four questions asking the patients how worried they are about getting melanoma and how this impacts their current lifestyle.
The patients choose the answers on a 5-point scale ranging from 'not at all worried' (best answer) to 'worried almost all the time' (worst answer).
|
Up to 12 months following randomisation.
|
The impact of receiving ASICA on anxiety and depression
Lasso di tempo: Up to 12 months following randomisation.
|
This outcome will be measured using Hospital Anxiety and Depression Scale (HADS).
HADS was devised to measure anxiety and depression in a general medical population of patients.
The questionnaire comprises seven questions for anxiety and seven questions for depression.
The patients choose the answers on a 4-point scale ranging from 'not at all' (best answer) to 'all the time' (worst answer).
Each item on the questionnaire is scored from 0-3 leading to a score range of 0 and 21 for each subscales (anxiety or depression).
For both scales, scores of less than 7 indicate non-cases, scores of 8-10 indicate mild anxiety/depression, scores of 11-14 indicate moderate anxiety/depression, and scores of 15-21 indicate severe anxiety/depression.
|
Up to 12 months following randomisation.
|
The impact of receiving ASICA quality of life.
Lasso di tempo: Up to 12 months following randomisation.
|
This outcome will be measured using EQ-5D-5L questionnaire.
EQ-5D-5L consists of two sections - descriptive system and a visual scale.
The descriptive system comprises of five questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each question has five possible answers ranging from: no problems, slight problems, moderate problems, severe problems and extreme problems.
The patient chooses the most appropriate statement in each of the five questions.
This decision results in a 1-digit number that expresses the level selected for that question.
The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The higher the number the worse the health state is.
The visual scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The worst health you can imagine' (score of 0) and 'The best health you can imagine' (score of 100).
|
Up to 12 months following randomisation.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The impact of receiving ASICA on detection rate of second primary and recurrent melanoma
Lasso di tempo: Up to 12 months following randomisation.
|
The questionnaire consists of 14 questions asking patients whether they have ever and in the past 12 month checked any part of their skin for signs of skin cancer (yes/no answer).
If so, how often (5 point scale ranging from 'zero' to 'more than six times') and which areas of the body were checked.
The patients are also asked whether they used a mirror or get help to check difficult to reach areas of their body.
The patients are also asked how confident they are about being able to check their own skin.
Patients choose the answers on a 10-point scale ranging from 'not at all confident' (worst answer) to 'highly confident' (best answer).
The final set of questions ask patients whether they have found anything concerning during their last skin check (yes/no answer) and if so what action was taken by the patient (watched it/showed it to a relative/showed it to a professional) and how quickly (immediately, in few days, in a week, in a month, other).
|
Up to 12 months following randomisation.
|
The impact of receiving ASICA on adherence to and self-efficacy to conduct TSSE in future
Lasso di tempo: Up to 12 months following randomisation.
|
This outcome will be measured using a questionnaire designed to determine what the patients think about examining their own skin.
The questionnaire consists of nine statements about how important it is to patients to check their skin, do they do it regularly, does it make them anxious, whether they feel confident about having their skin checked by a professional, and do they make plans regarding when and where they will have their skin checked.
For each statement, patients indicate whether they strongly disagree, disagree, agree, strongly agree, or are unsure.
|
Up to 12 months following randomisation.
|
The impact of receiving ASICA on patterns of UK NHS resource use
Lasso di tempo: Up to 12 months following randomisation.
|
This outcome will be measured using a questionnaire designed to determine whether patients used NHS because of their skin problems.
The set of seven questions is about any appointments within the NHS that patients may have had about their skin in the past 12 months.
Patients are asked whether they had any appointments with a medical professional (GP/nurse/other) for their skin in the past 12 months (yes/no answer), how many (free text) and at what setting (visit at the practice/visit at home/telephone).
Patients are also asked about operations or any other treatment they may have had on their skin in the past 12 months (free text).
Patients are also asked to list any prescribed medicines or non-prescribed skin products in the last 12 months and their cost (free text).
|
Up to 12 months following randomisation.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Peter Murchie, MBChB, PhD, University of Aberdeen
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Murchie P, Constable L, Hall S, Brant W, Allan J, Johnston M, Masthoff J, Lee A, Treweek S, Ayansina D, Proby C, Rahman K, Walter F, Burrows N, Durrani A, Maclennan G. The Achieving Self-directed Integrated Cancer Aftercare Intervention for Detection of Recurrent and Second Primary Melanoma in Survivors of Melanoma: Pilot Randomized Controlled Trial. JMIR Cancer. 2022 Sep 8;8(3):e37539. doi: 10.2196/37539.
- Allan JL, Johnston DW, Johnston M, Murchie P. Describing, predicting and explaining adherence to total skin self-examination (TSSE) in people with melanoma: a 12-month longitudinal study. BMJ Open. 2022 Aug 30;12(8):e056755. doi: 10.1136/bmjopen-2021-056755.
- Reilly F, Contstable L, Brant W, Rahman K, Durrani A, Burrows N, Proby C, Allan J, Johnston M, Johnston D, Walter F, Murchie P. Achieving integrated self-directed Cancer aftercare (ASICA) for melanoma: how a digital intervention to support total skin self-examination was used by people treated for cutaneous melanoma. BMC Cancer. 2021 Nov 13;21(1):1217. doi: 10.1186/s12885-021-08959-2.
- Murchie P, Masthoff J, Walter FM, Rahman K, Allan JL, Burrows N, Proby C, Lee AJ, Johnston M, Durrani A, Depasquale I, Brant B, Neilson A, Meredith F, Treweek S, Hall S, McDonald A. Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma. Trials. 2019 Jun 3;20(1):318. doi: 10.1186/s13063-019-3453-x.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
12 gennaio 2018
Completamento primario (Effettivo)
31 marzo 2020
Completamento dello studio (Effettivo)
31 marzo 2020
Date di iscrizione allo studio
Primo inviato
23 ottobre 2017
Primo inviato che soddisfa i criteri di controllo qualità
26 ottobre 2017
Primo Inserito (Effettivo)
1 novembre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 aprile 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2-028-17
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su ASICA digital app
-
Scripps Whittier Diabetes InstituteSan Diego State University; University of California, San DiegoCompletatoDiabete mellito, tipo 2Stati Uniti
-
Sally CHANCompletato
-
Scripps Whittier Diabetes InstituteNational Center for Advancing Translational Sciences (NCATS)Reclutamento
-
Mount Sinai Hospital, CanadaCanadian Institutes of Health Research (CIHR); MOUNT SINAI HOSPITAL; Trillium Health...ReclutamentoAnziani con bisogni assistenziali complessiCanada
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; R...ReclutamentoMalattia infiammatoria intestinale (IBD)Stati Uniti
-
University of California, DavisIscrizione su invitoCompromissione cognitiva lieve | Malattia prodromica di Alzheimer | Disturbi cognitivi soggettiviStati Uniti
-
University of TorontoOntario Ministry of Health and Long Term Care; Canadian Health Services Research...SconosciutoComputer, palmari | Valutazione dei risultati, pazienteCanada
-
Allurion TechnologiesCompletato
-
Scripps Whittier Diabetes InstituteReclutamento
-
Weill Medical College of Cornell UniversitySconosciuto