跳至主要内容
临床试验/NCT05460650
NCT05460650已完成不适用

Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer

University of Manchester1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年11月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Acceptability and usability of the app

研究概览

简要总结

It is estimated that around 20% of breast cancers (BC) in the UK are preventable through adherence to appropriate health behaviours, i.e., healthy diet, physical activity, limited alcohol, not smoking, and that women at increased risk of BC could benefit from greater decreases in risk than the general population via health behaviour changes. Young women (age <35 years) who are at increased risk of developing BC currently receive little or no information regarding health behaviours and BC risk, or support for behaviour change. This feasibility study aims to explore whether a novel app is acceptable to women at increased risk and could potentially engage them with improved health behaviours which could reduce their future risk of BC.

详细描述

Aims

  1. To assess the acceptability and usability of the app to young women at increased risk of BC
  2. To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention

Objectives

  1. Explore views of users of the experiences during and after using the app
  2. Explore views of users on their experience of the two different recruitment procedures (targeted mailshot, or social media, newsletters and websites), and the online consent procedure.
  3. Interpret user data from the app including frequency and patterns of use of the different functions
  4. Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study
  5. Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study.
  6. Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support.
  7. Quantify researcher time required for cleaning and analysis of app data.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Age 18-35 years
  • •Live in the UK
  • •Moderate or high risk of BC (see 6.5 for definition)
  • •Ability to communicate in English
  • •Ability to download and use an app (available on both ioS and Android)

排除标准

  • •Previous BC (other cancers will not be excluded)
  • •Previous preventative mastectomy
  • •Currently trying to gain weight
  • •Previous weight loss surgery
  • •Currently taking weight loss medication, prescribed (for example orlistat, liraglutide, Naltrexone/Bupropion [Mysimba]) or other
  • •Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis
  • •Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm
  • •Current alcohol or drug dependency
  • •Current or previous diagnosis of an eating disorder

研究组 & 干预措施

Receives app

Experimental

All women in the study will receive access to the app.

干预措施: App Promoting Healthy Behaviours (Behavioral)

结局指标

主要结局

Acceptability and usability of the app

时间窗: Two months

Assess acceptability and usability of the app by interviews

次要结局

  • Acceptability and usability of the app via questionnaire(Two months)
  • Number of interactions with the private Facebook group(Two months)
  • Study uptake numbers via invite letter and social media posts(Two months)
  • Acceptability of study recruitment, consent and trial procedures(Two months)
  • Errors in app data entry(Two months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Pegington

Senior Research Dietitian

University of Manchester

研究点 (1)

Loading locations...

相似试验