Recruiting

Mobile Health App

Sponsor:

Centre for Global eHealth Innovation

Code:

NCT03207113

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ned

Study Details

Brief summary:

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 with patients (n=20) and their caregivers (n=10) post-study will also be conducted to gain insight into their experience with the application.

Conditions

Prostate Cancer

Study ID

NCT03207113

Start date

Oct, 2017

Status verified date

Oct, 2017

Completion date

Mar, 2019

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Patients must meet the following eligibility criteria to be enrolled into the study:

  • 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

Study Design

Enrollment

610 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Ned

Prostate cancer survivorship application.

Primary outcome measure

  • Adoption [ Time Frame: Continuous throughout 12 month study duration ]
  • Acceptability [ Time Frame: Continuous throughout 12 month study duration ]

Central Contacts and Locations

Central contacts

Quynh Pham, MSc

1-647-667-2573qpham@ehealthinnovation.org

Locations

Centre for Global eHealth Innovation

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Quynh Pham, MSc

1-647-667-2573qpham@ehealthinnovation.org

Principal Investigator:

Andrew Feifer, MD, MPH

More Information

Sponsor

Centre for Global eHealth Innovation

Last update posted

Oct 12, 2017

Last verified

Oct, 2017

Keywords

  • prostate-specific antigen
  • prostate cancer survivorship
  • mobile health
  • realist evaluation
  • case study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Global eHealth Innovation on 2017-10-12.