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

2021年4月27日 更新者:University of Aberdeen

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

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.

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

240

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Aberdeen、英国
        • University of Aberdeen
      • Cambridge、英国
        • Addenbrookes Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Control group will attend their routine melanoma follow-ups
实验性的:Intervention
The intervention group will use the ASICA app in addition to their routine follow-ups
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The impact of receiving ASICA on cancer worry
大体时间:Up to 12 months following randomisation.
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
大体时间:Up to 12 months following randomisation.
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.
大体时间:Up to 12 months following randomisation.
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.

次要结果测量

结果测量
措施说明
大体时间
The impact of receiving ASICA on detection rate of second primary and recurrent melanoma
大体时间:Up to 12 months following randomisation.
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).
Up to 12 months following randomisation.
The impact of receiving ASICA on adherence to and self-efficacy to conduct TSSE in future
大体时间:Up to 12 months following randomisation.
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.
Up to 12 months following randomisation.
The impact of receiving ASICA on patterns of UK NHS resource use
大体时间:Up to 12 months following randomisation.
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).
Up to 12 months following randomisation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:Peter Murchie, MBChB, PhD、University of Aberdeen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月12日

初级完成 (实际的)

2020年3月31日

研究完成 (实际的)

2020年3月31日

研究注册日期

首次提交

2017年10月23日

首先提交符合 QC 标准的

2017年10月26日

首次发布 (实际的)

2017年11月1日

研究记录更新

最后更新发布 (实际的)

2021年4月28日

上次提交的符合 QC 标准的更新

2021年4月27日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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