Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT05460650
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Sponsor:
University of Manchester
Organization:
Study Overview
Official Title:
Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: