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

Peter Murchie (Corresponding Author), Judith Masthoff, Fiona M. Walter, Kazi Rahman, Julia L. Allan, Nigel Burrows, Charlotte Proby, Amanda J. Lee, Marie Johnston, Amer Durrani, Ivan Depasquale, Billy Brant, Aileen Neilson, Fiona Meredith, Shaun P. Treweek, Susan J. Hall, Alison M. McDonald

Research output: Contribution to journalArticle

Abstract

Background

Melanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4–8% develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up.

Methods

We aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation.

Discussion

If the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.

Trial registration

Clinical Trials.gov, NCT03328247. Registered on 1 November 2017.

Original languageEnglish
Article number318
Number of pages11
JournalTrials
Volume20
DOIs
Publication statusPublished - 3 Jun 2019

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Aftercare
Melanoma
Self-Examination
Neoplasms
Skin
National Health Programs
Random Allocation
Recurrence
Secondary Care
Health Resources
Scotland
Self Efficacy
England
Tablets
Health Services
Survivors
Outpatients
Anxiety
Randomized Controlled Trials
Guidelines

Keywords

  • primary care
  • melanoma
  • cancer
  • randomised controlled trial
  • survivorship
  • self-directed care
  • e-health
  • ASICA
  • Self-directed care
  • Melanoma
  • Survivorship
  • Primary care
  • Randomised controlled trial
  • Cancer

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine (miscellaneous)

Cite this

@article{82f024900793432da90f836be9c28003,
title = "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",
abstract = "BackgroundMelanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20{\%} of patients with early-stage melanoma experience a recurrence and 4–8{\%} develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up.MethodsWe aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation.DiscussionIf the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.Trial registrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017.",
keywords = "primary care, melanoma, cancer, randomised controlled trial, survivorship, self-directed care, e-health, ASICA, Self-directed care, Melanoma, Survivorship, Primary care, Randomised controlled trial, Cancer",
author = "Peter Murchie and Judith Masthoff and Walter, {Fiona M.} and Kazi Rahman and Allan, {Julia L.} and Nigel Burrows and Charlotte Proby and Lee, {Amanda J.} and Marie Johnston and Amer Durrani and Ivan Depasquale and Billy Brant and Aileen Neilson and Fiona Meredith and Treweek, {Shaun P.} and Hall, {Susan J.} and McDonald, {Alison M.}",
note = "The authors gratefully acknowledge Joanna Kaniewska, Anne Duncan and Lynda Constable (trial management) for their contributions to the protocol and management of the study. Funding The study is supported by a grant from a Cancer Research UK Population Research Committee project award (C10673/A21685). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of Cancer Research UK. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of data, or writing of the report.",
year = "2019",
month = "6",
day = "3",
doi = "10.1186/s13063-019-3453-x",
language = "English",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma

T2 - 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

AU - Murchie, Peter

AU - Masthoff, Judith

AU - Walter, Fiona M.

AU - Rahman, Kazi

AU - Allan, Julia L.

AU - Burrows, Nigel

AU - Proby, Charlotte

AU - Lee, Amanda J.

AU - Johnston, Marie

AU - Durrani, Amer

AU - Depasquale, Ivan

AU - Brant, Billy

AU - Neilson, Aileen

AU - Meredith, Fiona

AU - Treweek, Shaun P.

AU - Hall, Susan J.

AU - McDonald, Alison M.

N1 - The authors gratefully acknowledge Joanna Kaniewska, Anne Duncan and Lynda Constable (trial management) for their contributions to the protocol and management of the study. Funding The study is supported by a grant from a Cancer Research UK Population Research Committee project award (C10673/A21685). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of Cancer Research UK. The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis, or interpretation of data, or writing of the report.

PY - 2019/6/3

Y1 - 2019/6/3

N2 - BackgroundMelanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4–8% develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up.MethodsWe aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation.DiscussionIf the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.Trial registrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017.

AB - BackgroundMelanoma is common; 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased fivefold in 30 years. Melanoma affects old and young people, with poor prognosis once metastatic. UK guidelines recommend people treated for cutaneous melanoma receive extended outpatient, hospital follow up to detect recurrence or new primaries. Such follow up of the growing population of melanoma survivors is burdensome for both individuals and health services. Follow up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4–8% develop a new primary; the risk of either is highest in the first 5 years. Achieving Self-directed Integrated Cancer Aftercare (ASICA) is a digital intervention to increase total-skin-self-examination (TSSE) by people treated for melanoma, with usual follow up.MethodsWe aim to recruit 240 adults with a previous first-stage 0-2C primary cutaneous melanoma, from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet-based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL 5-dimension 5-level questionnaire (EQ-5D-5 L), and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomization, along with a 12-month review of clinical data. The primary timepoint for outcome analyses will be12 months after randomisation.DiscussionIf the ASICA intervention improves the practice of TSSE in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and National Health Service (NHS) resources. This study will determine if a full-scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed to determine the effectiveness of the intervention. ASICA is a pilot study evaluating the effectiveness of the practice of digitally supported TSSE in those affected by melanoma.Trial registrationClinical Trials.gov, NCT03328247. Registered on 1 November 2017.

KW - primary care

KW - melanoma

KW - cancer

KW - randomised controlled trial

KW - survivorship

KW - self-directed care

KW - e-health

KW - ASICA

KW - Self-directed care

KW - Melanoma

KW - Survivorship

KW - Primary care

KW - Randomised controlled trial

KW - Cancer

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U2 - 10.1186/s13063-019-3453-x

DO - 10.1186/s13063-019-3453-x

M3 - Article

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 318

ER -