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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05460650
Other study ID # REC 22/WA/0164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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