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

Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care: a Realist Case Study of the Ned App.

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Ned

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.

• Study Type: Interventional
• Enrollment (Anticipated): 610
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Quynh Pham, MSc; Phone Number: 1-647-667-2573; Email: qpham@ehealthinnovation.org

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Centre for Global eHealth Innovation
      • Contact: Quynh Pham, MSc; Phone Number: 1-647-667-2573; Email: qpham@ehealthinnovation.org
      • Principal Investigator: Andrew Feifer, MD, MPH
      • Sub-Investigator: Joseph A. Cafazzo, PhD, PEng
      • Sub-Investigator: Quynh Pham, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Behavioral: Ned; Prostate cancer survivorship application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 month study duration
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.	12 month study duration
Unmet needs	Unmet needs will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.	12 month study duration
Self-efficacy	Self-efficacy will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.	12 month study duration
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.	12 month study duration

Collaborators and Investigators

• Sponsor: Centre for Global eHealth Innovation
• Collaborators: University Health Network, Toronto; Trillium Health Partners
• Investigators: Principal Investigator: Andrew Feifer, MD, MPH, Trillium Health Partners

Publications and helpful links

Helpful Links

• Ned website.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (ACTUAL): July 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: mobile health; prostate-specific antigen; prostate cancer survivorship; realist evaluation; case study
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: THP REB ID#826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No