Clinical trial NCT05460650: Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Official title: Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Overweight and Obesity
Diet, Healthy
Weight Gain
Alcohol Drinking
Smoking Behaviors
Healthy Nutrition
Healthy Lifestyle
Healthy Eating Index
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Manchester University NHS Foundation Trust
First posted: 2022-07-15
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Acceptability and usability of the app
timeFrame: Two months
Secondary outcomes:
measure: Acceptability of study recruitment, consent and trial procedures
timeFrame: Two months
measure: Study uptake numbers via invite letter and social media posts
timeFrame: Two months
measure: Acceptability and usability of the app via questionnaire
timeFrame: Two months
measure: Errors in app data entry
timeFrame: Two months
measure: Number of interactions with the private Facebook group
timeFrame: Two months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: