NCT03207113

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
610

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

June 29, 2017

Last Update Submit

October 10, 2017

Conditions

Prostate Cancer

Keywords

prostate-specific antigenprostate cancer survivorshipmobile healthrealist evaluationcase study

Outcome Measures

Primary Outcomes (2)

  • Adoption

    The number of patients, caregivers and clinicians who are invited to open a Ned account, and the consequent number of Ned accounts created; measured using analytics log data.

    Continuous throughout 12 month study duration

  • Acceptability

    The perception of Ned as an acceptable addition to the standard of care; measured using (i) analytics log data (ii) validated questionnaires (iii) semi-structured interviews.

    Continuous throughout 12 month study duration

Secondary Outcomes (5)

  • Health-related quality of life

    12 month study duration

  • Satisfaction with cancer care

    12 month study duration

  • Unmet needs

    12 month study duration

  • Self-efficacy

    12 month study duration

  • Prostate cancer-related levels of anxiety

    12 month study duration

Study Arms (1)

Ned Group

EXPERIMENTAL

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.

Behavioral: Ned

Interventions

NedBEHAVIORAL

Prostate cancer survivorship application.

Ned Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre for Global eHealth Innovation

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Andrew Feifer, MD, MPH

    Trillium Health Partners

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quynh Pham, MSc

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

October 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)