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Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma (ASICA)

27. April 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

240

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
      • Aberdeen, Vereinigtes Königreich
        • University of Aberdeen
      • Cambridge, Vereinigtes Königreich
        • Addenbrookes Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control
Control group will attend their routine melanoma follow-ups
Experimental: Intervention
The intervention group will use the ASICA app in addition to their routine follow-ups
Sonstiges: ASICA digital app
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The impact of receiving ASICA on cancer worry
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The impact of receiving ASICA on detection rate of second primary and recurrent melanoma
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Aberdeen

Mitarbeiter

Cancer Research UK

Ermittler

  • Hauptermittler: Peter Murchie, MBChB, PhD, University of Aberdeen

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. Januar 2018

Primärer Abschluss (Tatsächlich)

31. März 2020

Studienabschluss (Tatsächlich)

31. März 2020

Studienanmeldedaten

Zuerst eingereicht

23. Oktober 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Oktober 2017

Zuerst gepostet (Tatsächlich)

1. November 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2-028-17

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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