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

P. Murchie (Lead / Corresponding author), J. Masthoff, F. M. Walter, K. Rahman, J. L. Allan, N. Burrows, C. Proby, A. J. Lee, M. Johnston, A. Durrani, I. Depasquale, B. Brant, A. Neilson, F. Meredith, S. Treweek, S. Hall, A. McDonald

Research output: Contribution to journalArticle

41 Downloads (Pure)

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
Pages (from-to)1-11
Number of pages11
JournalTrials
Volume20
Issue number1
DOIs
Publication statusPublished - 3 Jun 2019

Fingerprint

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

Keywords

  • Primary care
  • Melanoma
  • Cancer
  • Randomised controlled trial
  • Survivorship
  • Self-directed care
  • e-health
  • ASICA

Cite this

Murchie, P. ; Masthoff, J. ; Walter, F. M. ; Rahman, K. ; Allan, J. L. ; Burrows, N. ; Proby, C. ; Lee, A. J. ; 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. In: Trials. 2019 ; Vol. 20, No. 1. pp. 1-11.
@article{da6895758f47403caf53d7bdb840a2d6,
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 = "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.",
keywords = "Primary care, Melanoma, Cancer, Randomised controlled trial, Survivorship, Self-directed care, e-health, ASICA",
author = "P. Murchie and J. Masthoff and Walter, {F. M.} and K. Rahman and Allan, {J. L.} and N. Burrows and C. Proby and Lee, {A. J.} and M. Johnston and A. Durrani and I. Depasquale and B. Brant and A. Neilson and F. Meredith and S. Treweek and S. Hall and A. McDonald",
note = "The study is supported by a grant from a Cancer Research UK Population Research Committee project award (C10673/A21685).",
year = "2019",
month = "6",
day = "3",
doi = "10.1186/s13063-019-3453-x",
language = "English",
volume = "20",
pages = "1--11",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

}

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 2019, '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, vol. 20, no. 1, 318, pp. 1-11. https://doi.org/10.1186/s13063-019-3453-x

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. / Murchie, P. (Lead / Corresponding author); Masthoff, J.; Walter, F. M.; Rahman, K.; Allan, J. L.; Burrows, N.; Proby, C.; Lee, A. J.; Johnston, M.; Durrani, A.; Depasquale, I.; Brant, B.; Neilson, A.; Meredith, F.; Treweek, S.; Hall, S.; McDonald, A.

In: Trials, Vol. 20, No. 1, 318, 03.06.2019, p. 1-11.

Research output: Contribution to journalArticle

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, P.

AU - Masthoff, J.

AU - Walter, F. M.

AU - Rahman, K.

AU - Allan, J. L.

AU - Burrows, N.

AU - Proby, C.

AU - Lee, A. J.

AU - Johnston, M.

AU - Durrani, A.

AU - Depasquale, I.

AU - Brant, B.

AU - Neilson, A.

AU - Meredith, F.

AU - Treweek, S.

AU - Hall, S.

AU - McDonald, A.

N1 - The study is supported by a grant from a Cancer Research UK Population Research Committee project award (C10673/A21685).

PY - 2019/6/3

Y1 - 2019/6/3

N2 - 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.

AB - 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.

KW - Primary care

KW - Melanoma

KW - Cancer

KW - Randomised controlled trial

KW - Survivorship

KW - Self-directed care

KW - e-health

KW - ASICA

U2 - 10.1186/s13063-019-3453-x

DO - 10.1186/s13063-019-3453-x

M3 - Article

C2 - 31159849

VL - 20

SP - 1

EP - 11

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 318

ER -