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Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care.

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ned
Sponsored by
Centre for Global eHealth Innovation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate-specific antigen, prostate cancer survivorship, mobile health, realist evaluation, case study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Global eHealth InnovationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ned Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Health-related quality of life
Health-related quality of life will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Satisfaction with cancer care
Satisfaction with cancer care will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Unmet needs
Unmet needs will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Self-efficacy
Self-efficacy will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Prostate cancer-related levels of anxiety
Prostate cancer-related levels of anxiety will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.

Full Information

First Posted
June 29, 2017
Last Updated
October 10, 2017
Sponsor
Centre for Global eHealth Innovation
Collaborators
Trillium Health Partners, University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03207113
Brief Title
Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care.
Official Title
Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care: a Realist Case Study of the Ned App.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Global eHealth Innovation
Collaborators
Trillium Health Partners, University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
By 2030, prostate cancer will be the most commonly diagnosed cancer in North America. To mitigate this impending challenge, comprehensive support mechanisms for disease and treatment-specific changes in health and wellbeing must be proactively designed and thoughtfully implemented for streamlined survivorship care. Mobile health applications have been lauded as a promising complement to current outpatient treatment and monitoring strategies, but have not yet been widely used to support prostate cancer survivorship needs. A realist evaluation is needed to examine the impact of such applications on the prostate cancer survivorship experience. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate-specific antigen, prostate cancer survivorship, mobile health, realist evaluation, case study

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
610 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ned Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ned
Intervention Description
Prostate cancer survivorship application.
Primary Outcome Measure Information:
Title
Adoption
Description
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.
Time Frame
Continuous throughout 12 month study duration
Title
Acceptability
Description
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.
Time Frame
Continuous throughout 12 month study duration
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
Health-related quality of life will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Time Frame
12 month study duration
Title
Satisfaction with cancer care
Description
Satisfaction with cancer care will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Time Frame
12 month study duration
Title
Unmet needs
Description
Unmet needs will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Time Frame
12 month study duration
Title
Self-efficacy
Description
Self-efficacy will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Time Frame
12 month study duration
Title
Prostate cancer-related levels of anxiety
Description
Prostate cancer-related levels of anxiety will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.
Time Frame
12 month study duration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quynh Pham, MSc
Phone
1-647-667-2573
Email
qpham@ehealthinnovation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Feifer, MD, MPH
Organizational Affiliation
Trillium Health Partners
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Global eHealth Innovation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quynh Pham, MSc
Phone
1-647-667-2573
Email
qpham@ehealthinnovation.org
First Name & Middle Initial & Last Name & Degree
Andrew Feifer, MD, MPH
First Name & Middle Initial & Last Name & Degree
Joseph A. Cafazzo, PhD, PEng
First Name & Middle Initial & Last Name & Degree
Quynh Pham, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://getned.com
Description
Ned website.

Learn more about this trial

Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care.

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