Breast CancerNCT05460650
Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
A study testing App Promoting Healthy Behaviours in people with Breast Cancer and Overweight and Obesity, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Overweight and Obesity, Diet, Healthy
- What is being tested?
- App Promoting Healthy Behaviours
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2022to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester
About this study
Official title: Evaluation of 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.
Read the 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.
- Conditions
- Breast Cancer, Overweight and Obesity, Diet, Healthy, Weight Gain, Alcohol Drinking, Smoking Behaviors
- Being tested
- App Promoting Healthy Behaviours
- Medical subject headings
- Breast Neoplasms, Overweight, Obesity, Weight Gain, Alcohol Drinking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App Promoting Healthy BehavioursBehavioural
Women on the study will receive two months access to the app.
| Study group | Role | What they receive |
|---|---|---|
| Receives app | Experimental | All women in the study will receive access to the app. Receives: Behavioral: App Promoting Healthy Behaviours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and usability of the app
Assess acceptability and usability of the app by interviews
Measured: Two months
Secondary outcomes (5)
Acceptability of study recruitment, consent and trial procedures
Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts
Measured: Two months
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
Measured: Two months
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.
Measured: Two months
Errors in app data entry
Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.
Measured: Two months
Number of interactions with the private Facebook group
Number of participant interactions in the Facebook group during the two months.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start3 Nov 2022
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Mary Pegington, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460650
- Sponsor's protocol ID
- REC 22/WA/0164
- Status last verified
- Mar 2023
- First submitted
- 23 Jun 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36525287
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer
- ClinicalTrials.gov ID
- NCT05460650
- Acronym / sponsor ID
- REC 22/WA/0164
- Conditions
- Breast Cancer, Overweight and Obesity, Diet, Healthy, Weight Gain, Alcohol Drinking, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receives app | Experimental | Behavioral: App Promoting Healthy BehavioursAll women in the study will receive access to the app. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App Promoting Healthy BehavioursWomen on the study will receive two months access to the app. | Behavioural | Receives app |
Primary outcome
Acceptability and usability of the app
Time frame: Two months
Assess acceptability and usability of the app by interviews
5 secondary outcomes
Acceptability of study recruitment, consent and trial procedures
Time frame: Two months
Study uptake numbers via invite letter and social media posts
Time frame: Two months
Acceptability and usability of the app via questionnaire
Time frame: Two months
Errors in app data entry
Time frame: Two months
Number of interactions with the private Facebook group
Time frame: Two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 36525287Pegington 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Promoting Healthy Behaviours in people with Breast Cancer and Overweight and Obesity, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and usability of the app (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.