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

NCT ID: NCT05460650

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2023-03-10

Brief Summary

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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

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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.

Conditions

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Breast Cancer Overweight and Obesity Diet, Healthy Weight Gain Alcohol Drinking Smoking Behaviors Healthy Nutrition Healthy Lifestyle Healthy Eating Index

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Receives app

All women in the study will receive access to the app.

Group Type EXPERIMENTAL

App Promoting Healthy Behaviours

Intervention Type BEHAVIORAL

Women on the study will receive two months access to the app.

Interventions

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App Promoting Healthy Behaviours

Women on the study will receive two months access to the app.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role lead

Responsible Party

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Mary Pegington

Senior Research Dietitian

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Pegington M, Davies A, Mueller J, Cholerton R, Howell A, Evans DG, Howell SJ, French DP, Harvie M. Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study. JMIR Res Protoc. 2022 Dec 16;11(12):e41246. doi: 10.2196/41246.

Reference Type DERIVED
PMID: 36525287 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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REC 22/WA/0164

Identifier Type: -

Identifier Source: org_study_id

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