Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma (ASICA)
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
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
Тип исследования
Тип исследования
Регистрация (Действительный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Aberdeen, Соединенное Королевство
- University of Aberdeen
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Cambridge, Соединенное Королевство
- Addenbrookes Hospital
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Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
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Без вмешательства: Control
Control group will attend their routine melanoma follow-ups
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Экспериментальный: Intervention
The intervention group will use the ASICA app in addition to their routine follow-ups
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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.
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Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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The impact of receiving ASICA on cancer worry
Временное ограничение: Up to 12 months following randomisation.
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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).
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Up to 12 months following randomisation.
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The impact of receiving ASICA on anxiety and depression
Временное ограничение: Up to 12 months following randomisation.
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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.
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Up to 12 months following randomisation.
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The impact of receiving ASICA quality of life.
Временное ограничение: Up to 12 months following randomisation.
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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).
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Up to 12 months following randomisation.
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Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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The impact of receiving ASICA on detection rate of second primary and recurrent melanoma
Временное ограничение: Up to 12 months following randomisation.
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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).
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Up to 12 months following randomisation.
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The impact of receiving ASICA on adherence to and self-efficacy to conduct TSSE in future
Временное ограничение: Up to 12 months following randomisation.
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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.
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Up to 12 months following randomisation.
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The impact of receiving ASICA on patterns of UK NHS resource use
Временное ограничение: Up to 12 months following randomisation.
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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).
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Up to 12 months following randomisation.
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Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Главный следователь: Peter Murchie, MBChB, PhD, University of Aberdeen
Публикации и полезные ссылки
Общие публикации
- 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.
- 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Действительный)
Первичное завершение
Завершение исследования (Действительный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 2-028-17
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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