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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Aims To assess the acceptability and usability of the app to young women at increased risk of BC To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention Objectives Explore views of users of the experiences during and after using the app 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. Interpret user data from the app including frequency and patterns of use of the different functions Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study. Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support. Quantify researcher time required for cleaning and analysis of app data.

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

Conditions
-----------------
Breast Cancer, Overweight and Obesity, Diet, Healthy, Weight Gain, Alcohol Drinking, Smoking Behaviors, Healthy Nutrition, Healthy Lifestyle, Healthy Eating Index

Intervention / Treatment
-----------------
* Behavioral: App Promoting Healthy Behaviours


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 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) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receives app<br>All women in the study will receive access to the app. | Behavioral: App Promoting Healthy Behaviours<br>* Women on the study will receive two months access to the app.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and usability of the app | Assess acceptability and usability of the app by interviews | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of study recruitment, consent and trial procedures | Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts | Two months | 
| Study uptake numbers via invite letter and social media posts | Recruitment source of the participants from recruitment data, e.g. percentage response to mailshot, percentage uptake, number recruited via the postal invite letter and via social media | Two months | 
| Acceptability and usability of the app via questionnaire | Acceptability of the app, barriers and facilitators to engagement, likes and don't likes within app, usability, likelihood of extended use via questionnaire. | Two months | 
| Errors in app data entry | Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds. | Two months | 
| Number of interactions with the private Facebook group | Number of participant interactions in the Facebook group during the two months. | Two months |