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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460650
• Other study ID #: REC 22/WA/0164
• Status: Completed
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Breast Cancer
• Breast Neoplasms
• Diet, Healthy
• Healthy Lifestyle
• Overweight
• Overweight and Obesity
• Smoking Behaviors
• Weight Gain

Intervention

Behavioral:
• App Promoting Healthy Behaviours
Women on the study will receive two months access to the app.

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and usability of the app	Assess acceptability and usability of the app by interviews	Two months
Secondary	Acceptability of study recruitment, consent and trial procedures	Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts	Two months
Secondary	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
Secondary	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
Secondary	Errors in app data entry	Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.	Two months
Secondary	Number of interactions with the private Facebook group	Number of participant interactions in the Facebook group during the two months.	Two months