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

NCT03328247 | Completed

• 1 other identifier: 2-028-17
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (3)

• The impact of receiving ASICA on cancer worry

  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

  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.

  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.

Secondary Outcomes (3)

• The impact of receiving ASICA on detection rate of second primary and recurrent melanoma

  Up to 12 months following randomisation.

• The impact of receiving ASICA on adherence to and self-efficacy to conduct TSSE in future

  Up to 12 months following randomisation.

• The impact of receiving ASICA on patterns of UK NHS resource use

  Up to 12 months following randomisation.

Study Arms (2)

Control

NO INTERVENTION

Control group will attend their routine melanoma follow-ups

Intervention

EXPERIMENTAL

The intervention group will use the ASICA app in addition to their routine follow-ups

Other: ASICA digital app

Interventions

ASICA digital app OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18)
• Patients treated for stage 0-2C cutaneous melanoma within the preceding 24 months

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead
• Cancer Research UK: collaborator

Study Sites (2)

University of Aberdeen

Aberdeen, United Kingdom

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Related Publications (6)

• Reilly F, Wani N, Hall S, Morgan HM, Allan J, Constable L, Ntessalen M, Murchie P. User Experiences in a Digital Intervention to Support Total Skin Self-examination by Melanoma Survivors: Nested Qualitative Evaluation Embedded in a Randomized Controlled Trial. JMIR Dermatol. 2023 Feb 13;6:e39544. doi: 10.2196/39544.

  PMID: 37632942 DERIVED

• Ntessalen M, McCorkindale S, Krasniqi A, Morgan HM, Allan JL, Murchie P. Barriers and facilitators of adherence to the use of ASICA, a digital app designed to support people previously treated for melanoma: concise report of a qualitative study. Clin Exp Dermatol. 2023 Nov 16;48(12):1358-1360. doi: 10.1093/ced/llad279.

  PMID: 37611174 DERIVED

• 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.

  PMID: 36074560 DERIVED

• 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.

  PMID: 36041758 DERIVED

• 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.

  PMID: 34774015 DERIVED

• 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.

  PMID: 31159849 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Murchie, MBChB, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 1, 2017
• Study Start: January 12, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)