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

University of Manchester

Status: Completed

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

Treatments: Behavioral: App Promoting Healthy Behaviours

Study type: Interventional

Funder types: Other

Identifiers

NCT05460650

REC 22/WA/0164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Receives app

Experimental group

Description:

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

Treatment:

Behavioral: App Promoting Healthy Behaviours