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

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ClinicalTrials.gov Identifier: NCT03207113
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Trillium Health Partners
University Health Network, Toronto
Information provided by (Responsible Party):
Centre for Global eHealth Innovation

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Ned Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive 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.
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Adoption [ Time Frame: Continuous throughout 12 month study duration ]
    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.

  2. Acceptability [ Time Frame: Continuous throughout 12 month study duration ]
    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 :
  1. Health-related quality of life [ Time Frame: 12 month study duration ]
    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.

  2. Satisfaction with cancer care [ Time Frame: 12 month study duration ]
    Satisfaction with cancer care will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.

  3. Unmet needs [ Time Frame: 12 month study duration ]
    Unmet needs will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.

  4. Self-efficacy [ Time Frame: 12 month study duration ]
    Self-efficacy will be measured using a validated questionnaire. Data will be collected at baseline, 2 months, 6 months, and 12 months.

  5. Prostate cancer-related levels of anxiety [ Time Frame: 12 month study duration ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207113


Contacts
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Contact: Quynh Pham, MSc 1-647-667-2573 qpham@ehealthinnovation.org

Locations
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Canada, Ontario
Centre for Global eHealth Innovation Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Quynh Pham, MSc    1-647-667-2573    qpham@ehealthinnovation.org   
Principal Investigator: Andrew Feifer, MD, MPH         
Sub-Investigator: Joseph A. Cafazzo, PhD, PEng         
Sub-Investigator: Quynh Pham, MSc         
Sponsors and Collaborators
Centre for Global eHealth Innovation
Trillium Health Partners
University Health Network, Toronto
Investigators
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Principal Investigator: Andrew Feifer, MD, MPH Trillium Health Partners

Additional Information:
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Responsible Party: Centre for Global eHealth Innovation
ClinicalTrials.gov Identifier: NCT03207113     History of Changes
Other Study ID Numbers: THP REB ID#826
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Centre for Global eHealth Innovation:
prostate-specific antigen
prostate cancer survivorship
mobile health
realist evaluation
case study

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases