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

Not Applicable

Completed

• Conditions: Smoking Behaviors; Healthy Lifestyle; Breast Cancer; Healthy Nutrition; Healthy Eating Index; Alcohol Drinking; Overweight and Obesity; Weight Gain; Diet, Healthy
• Interventions: Behavioral: App Promoting Healthy Behaviours

• Registration Number: NCT05460650
• Lead Sponsor: University of Manchester

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

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.

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-15
• Study Start: 2022-11-03
• Status Verified: 2023-03
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Receives app	App Promoting Healthy Behaviours	All women in the study will receive access to the app.

Primary Outcome Measures

Name	Time	Method
Acceptability and usability of the app	Two months	Assess acceptability and usability of the app by interviews

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom