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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Alcohol Drinking; Breast Neoplasms; Overweight; Weight Gain
• Other Study ID Numbers: REC 22/WA/0164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After data analysis is complete, the fully anonymised data will be uploaded on to Figshare as per University of Manchester guidance and will remain there indefinitely.
• IPD Sharing Time Frame: After data analysis is complete, the fully anonymised data will be uploaded on to Figshare as per University of Manchester guidance and will remain there indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No