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OpenTrials
Completed

NCT Number: NCT05460650

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

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.

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Key information

Conditions

Breast Cancer Alcohol Drinking Behavior Body Weight Body Weight Changes Breast Diseases Breast Neoplasms Diet, Healthy Drinking Behavior Healthy Eating Index Healthy Lifestyle Healthy Nutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Smoking Smoking Behaviors Weight Gain

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App Promoting Healthy Behaviours

Behavioral

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

Primary outcomes

  1. Acceptability and usability of the app

    Time frame: Two months

    Assess acceptability and usability of the app by interviews

Secondary outcomes

  1. Acceptability of study recruitment, consent and trial procedures

    Time frame: Two months

    Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts

  2. Study uptake numbers via invite letter and social media posts

    Time frame: Two months

    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

  3. Acceptability and usability of the app via questionnaire

    Time frame: Two months

    Acceptability of the app, barriers and facilitators to engagement, likes and don't likes within app, usability, likelihood of extended use via questionnaire.

  4. Errors in app data entry

    Time frame: Two months

    Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.

  5. Number of interactions with the private Facebook group

    Time frame: Two months

    Number of participant interactions in the Facebook group during the two months.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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