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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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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.
Aims
Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receives app | Experimental | All women in the study will receive access to the app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App Promoting Healthy Behaviours | Behavioral | Women on the study will receive two months access to the app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and usability of the app | Assess acceptability and usability of the app by interviews | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of study recruitment, consent and trial procedures | Assess the feasibility of all study procedures by interviews by thematic analysis of transcripts | Two months |
| Study uptake numbers via invite letter and social media posts |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester University NHS Foundation Trust | Manchester | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525287 | Derived | 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. |
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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.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2022 |
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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
| 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. | Two months |
| Errors in app data entry | Quantification of errors in information inputted by participants, e.g. kg entered as stones and pounds. | Two months |
| Number of interactions with the private Facebook group | Number of participant interactions in the Facebook group during the two months. | Two months |
| Jun 23, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D050177 | Overweight |
| D009765 | Obesity |
| D015430 | Weight Gain |
| D000428 | Alcohol Drinking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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