Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-21 @ 12:41 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015430', 'term': 'Weight Gain'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-26', 'size': 404118, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-23T01:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability and usability of the app', 'timeFrame': 'Two months', 'description': 'Assess acceptability and usability of the app by interviews'}], 'secondaryOutcomes': [{'measure': 'Acceptability of study recruitment, consent and trial procedures', 'timeFrame': 'Two months', 'description': 'Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts'}, {'measure': 'Study uptake numbers via invite letter and social media posts', 'timeFrame': 'Two months', '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'}, {'measure': 'Acceptability and usability of the app via questionnaire', 'timeFrame': 'Two months', 'description': "Acceptability of the app, barriers and facilitators to engagement, likes and don't likes within app, usability, likelihood of extended use via questionnaire."}, {'measure': 'Errors in app data entry', 'timeFrame': 'Two months', 'description': 'Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds.'}, {'measure': 'Number of interactions with the private Facebook group', 'timeFrame': 'Two months', 'description': 'Number of participant interactions in the Facebook group during the two months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Overweight and Obesity', 'Diet, Healthy', 'Weight Gain', 'Alcohol Drinking', 'Smoking Behaviors', 'Healthy Nutrition', 'Healthy Lifestyle', 'Healthy Eating Index']}, 'referencesModule': {'references': [{'pmid': '36525287', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Aims\n\n1. To assess the acceptability and usability of the app to young women at increased risk of BC\n2. To assess the feasibility of study procedures before running a future efficacy study using the app as an intervention\n\nObjectives\n\n1. Explore views of users of the experiences during and after using the app\n2. 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.\n3. Interpret user data from the app including frequency and patterns of use of the different functions\n4. Analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study\n5. Assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study.\n6. Quantify health care professional (HCP) time required for administering the private Facebook chat group, and through e-mail/private message support.\n7. Quantify researcher time required for cleaning and analysis of app data.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 18-35 years\n* Live in the UK\n* Moderate or high risk of BC (see 6.5 for definition)\n* Ability to communicate in English\n* Ability to download and use an app (available on both ioS and Android)\n\nExclusion Criteria:\n\n* Previous BC (other cancers will not be excluded)\n* Previous preventative mastectomy\n* Currently trying to gain weight\n* Previous weight loss surgery\n* Currently taking weight loss medication, prescribed (for example orlistat, liraglutide, Naltrexone/Bupropion \\[Mysimba\\]) or other\n* Have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis\n* Current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm\n* Current alcohol or drug dependency\n* Current or previous diagnosis of an eating disorder'}, 'identificationModule': {'nctId': 'NCT05460650', 'briefTitle': 'Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Evaluation of Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer', 'orgStudyIdInfo': {'id': 'REC 22/WA/0164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receives app', 'description': 'All women in the study will receive access to the app.', 'interventionNames': ['Behavioral: App Promoting Healthy Behaviours']}], 'interventions': [{'name': 'App Promoting Healthy Behaviours', 'type': 'BEHAVIORAL', 'description': 'Women on the study will receive two months access to the app.', 'armGroupLabels': ['Receives app']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '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.', 'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Dietitian', 'investigatorFullName': 'Mary Pegington', 'investigatorAffiliation': 'University of Manchester'}}}}