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

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03207113
• Other study ID #: THP REB ID#826
• Status: Recruiting
• Phase: N/A
• First received: June 29, 2017
• Last updated: October 10, 2017
• Start date: October 2017
• Est. completion date: March 2019

Study information

• Verified date: October 2017
• Source: Centre for Global eHealth Innovation
• Contact: Quynh Pham, MSc
• Phone: 1-647-667-2573
• Email: qpham[@]ehealthinnovation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 610
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Ned
Prostate cancer survivorship application.

Locations

Country	Name	City	State
Canada	Centre for Global eHealth Innovation	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Global eHealth Innovation	Trillium Health Partners, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Ned website.