Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care.
NCT ID: NCT03207113
Last Updated: 2017-10-12
Study Results
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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UNKNOWN
NA
610 participants
INTERVENTIONAL
2017-10-31
2019-03-31
Brief Summary
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Detailed Description
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The investigators seek to gain an understanding of how a mobile health application for prostate cancer survivorship care called Ned ("No Evident Disease") is adopted and accepted by patients, caregivers and clinicians. The investigators also aim to determine the effect of Ned on health-related quality of life, satisfaction with cancer care, unmet needs, self-efficacy, and prostate cancer-related levels of anxiety.
The Ned case study is a 12-month mixed methods embedded single-case study with a nested within-group pre-post comparison of health outcomes. 400 patients, 200 caregivers, and 10 clinicians will be given access to Ned. Participants will be asked to complete study assessments at baseline, 2 months, 6 months and 12 months. 30 semi-structured qualitative interviews will be conducted with patients (n=20) and their caregivers (n=10) post-study to gain insight into their experience with the application.
This will be the first realist case study to evaluate an application for prostate cancer survivorship care. Prostate cancer survivors are set to increase in number and longevity, heightening the need for integrated survivorship solutions to provide them with optimal and durable outcomes. The knowledge gained from this study will comprehensively inform how and why Ned works, for whom, and in what circumstances. Understanding the impact of digital health interventions like Ned on how survivors care for themselves is critical to realising patient-centered care.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Ned Group
Participants in the Ned case study (patients, caregivers, clinicians) will receive access to the Ned application.
Ned ("No Evident Disease") is the first application to provide patients with access to individual-level prostate-specific antigen values streamed directly from the Ontario Laboratory Information System to their own smartphone. The application aims to promote self-care by informing patients directly of their PSA results and providing them with a personalised view of their own symptoms. It supports real-time clinical decision-making by providing clinicians with patient-reported outcomes collected in-app, and includes a curated educational feed and support group links.
Ned
Prostate cancer survivorship application.
Interventions
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Ned
Prostate cancer survivorship application.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Receiving care at the THP Mississauga Hospital or Credit Valley Hospital
* Pathology report confirming prostate cancer diagnosis via transrectal, transperineal or transurethral biopsy (standard 12-core template)
* Life expectancy \> 1 year
* No concomitant cancer diagnosis
* Own a device that is compatible with the Ned application and is web-enabled through a data plan and/or wifi capabilities (e.g. laptop, desktop, tablet, smartphone)
* Able to read, write and speak English
18 Years
MALE
No
Sponsors
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Trillium Health Partners
OTHER
University Health Network, Toronto
OTHER
Centre for Global eHealth Innovation
OTHER
Responsible Party
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Principal Investigators
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Andrew Feifer, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Trillium Health Partners
Locations
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Centre for Global eHealth Innovation
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Quynh Pham, MSc
Role: primary
Related Links
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Ned website.
Other Identifiers
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THP REB ID#826
Identifier Type: -
Identifier Source: org_study_id