Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Primary Purpose
Breast Cancer, Overweight and Obesity, Diet, Healthy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
App Promoting Healthy Behaviours
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
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
Sites / Locations
- Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Receives app
Arm Description
All women in the study will receive access to the app.
Outcomes
Primary Outcome Measures
Acceptability and usability of the app
Assess acceptability and usability of the app by interviews
Secondary Outcome Measures
Acceptability of study recruitment, consent and trial procedures
Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts
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
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.
Errors in app data entry
Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.
Number of interactions with the private Facebook group
Number of participant interactions in the Facebook group during the two months.
Full Information
NCT ID
NCT05460650
First Posted
June 23, 2022
Last Updated
March 28, 2023
Sponsor
University of Manchester
Collaborators
Manchester University NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05460650
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
Manchester University NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
To assess the acceptability and usability of the app to young women at increased risk of BC
To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention
Objectives
Explore views of users of the experiences during and after using the app
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.
Interpret user data from the app including frequency and patterns of use of the different functions
Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study
Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study.
Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support.
Quantify researcher time required for cleaning and analysis of app data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Overweight and Obesity, Diet, Healthy, Weight Gain, Alcohol Drinking, Smoking Behaviors, Healthy Nutrition, Healthy Lifestyle, Healthy Eating Index
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receives app
Arm Type
Experimental
Arm Description
All women in the study will receive access to the app.
Intervention Type
Behavioral
Intervention Name(s)
App Promoting Healthy Behaviours
Intervention Description
Women on the study will receive two months access to the app.
Primary Outcome Measure Information:
Title
Acceptability and usability of the app
Description
Assess acceptability and usability of the app by interviews
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Acceptability of study recruitment, consent and trial procedures
Description
Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts
Time Frame
Two months
Title
Study uptake numbers via invite letter and social media posts
Description
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
Time Frame
Two months
Title
Acceptability and usability of the app via questionnaire
Description
Acceptability of the app, barriers and facilitators to engagement, likes and don't likes within app, usability, likelihood of extended use via questionnaire.
Time Frame
Two months
Title
Errors in app data entry
Description
Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.
Time Frame
Two months
Title
Number of interactions with the private Facebook group
Description
Number of participant interactions in the Facebook group during the two months.
Time Frame
Two months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
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