Prostate CancerNCT03207113
Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalised Prostate Cancer Survivorship Care.
A study testing Ned in people with Prostate Cancer, run by Centre for Global eHealth Innovation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ned
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2017to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Global eHealth Innovation
Toronto, Ontario, M5G 2C4
Quynh Pham, MSc, 1-647-667-2573, qpham@ehealthinnovation.org
Andrew Feifer, MD, MPH
About this study
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.
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Ned
- Keywords
- prostate-specific antigen, prostate cancer survivorship, mobile health, realist evaluation, case study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NedBehavioural
Prostate cancer survivorship application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Ned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Continuous throughout 12 month study duration
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 month study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startOct 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Global eHealth Innovation
- Sponsor type
- University, hospital or other
- Collaborators
- Trillium Health Partners, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Andrew Feifer, MD, MPH, Principal investigator, Trillium Health Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207113
- Sponsor's protocol ID
- THP REB ID#826
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03207113
- Acronym / sponsor ID
- THP REB ID#826
- Conditions
- Prostate Cancer
- Keywords
- prostate-specific antigen, prostate cancer survivorship, mobile health, realist evaluation, case study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Centre for Global eHealth InnovationUniversity, hospital or other
- Collaborators
- Trillium Health Partners, University Health Network, Toronto
- Study start
- Oct 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ned Group | Experimental | Behavioral: NedParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NedProstate cancer survivorship application. | Behavioural | Ned Group |
Primary outcome
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.
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.
5 secondary outcomes
Health-related quality of life
Time frame: 12 month study duration
Satisfaction with cancer care
Time frame: 12 month study duration
Unmet needs
Time frame: 12 month study duration
Self-efficacy
Time frame: 12 month study duration
Prostate cancer-related levels of anxiety
Time frame: 12 month study duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Ned website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Feifer, MD, MPH principal investigator
Trillium Health Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ned in people with Prostate Cancer, run by Centre for Global eHealth Innovation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quynh Pham, MSc (1-647-667-2573, qpham@ehealthinnovation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: Continuous throughout 12 month study duration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.