Clinical trial NCT03328247: Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2017-11-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The impact of receiving ASICA on cancer worry
timeFrame: Up to 12 months following randomisation.
measure: The impact of receiving ASICA on anxiety and depression
timeFrame: Up to 12 months following randomisation.
measure: The impact of receiving ASICA quality of life.
timeFrame: Up to 12 months following randomisation.
Secondary outcomes:
measure: The impact of receiving ASICA on detection rate of second primary and recurrent melanoma
timeFrame: Up to 12 months following randomisation.
measure: The impact of receiving ASICA on adherence to and self-efficacy to conduct TSSE in future
timeFrame: Up to 12 months following randomisation.
measure: The impact of receiving ASICA on patterns of UK NHS resource use
timeFrame: Up to 12 months following randomisation.
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: University of Aberdeen
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: University of Aberdeen
name: Peter Murchie, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.