Prostate CancerNCT04486846
Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
A study testing eVisit in people with Prostate Cancer, run by Duke University at 4 sites in United States.
Trial summary
The purpose of this single institution pilot study is to determine the feasibility of implementing an eHealth prostate cancer surveillance program through the eVisit electronic medical record patient portal. 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?
- eVisit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2021to Mar 2022
- 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
Who may be able to join
- ≥ 18 years old with histologically confirmed prostate cancer
- Completed curative intent treatment to the prostate +/- pelvis
- Deemed to be "without evidence of active disease" by treating provider with at least 1 follow up visit 3 or more months after treatment completion
- MyChart account or willingness to open account
- Access to the internet
Who cannot join
- Documented extrapelvic metastases
- PSA meeting definition of recurrence (>0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) and rising with doubling time less than 1 year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke Cancer Institute Cary
Cary, North Carolina, 27518
Durham Regional Hospital
Durham, North Carolina, 27704
Duke University Medical Center
Durham, North Carolina, 27710
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
About this study
Official title: Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
The purpose of this single institution pilot study is to determine the feasibility of implementing an eHealth prostate cancer surveillance program through the eVisit electronic medical record patient portal. The investigators will assess patient compliance and satisfaction with eVisit follow up care in lieu of in person clinic visits.
Read the detailed description
Telehealth offers the opportunity to transform cancer surveillance into a patient-centered effort with shared leadership between patient and oncologist. Peer-to-peer electronic communications can improve the collaboration between oncologist and primary care provider (PCP) as patients transition back to primary care as their primary health provider. The investigators propose to test a patient-centered eHealth surveillance program utilizing novel asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using the electronic medical record's patient portal (eVisit).
- Conditions
- Prostate Cancer
- Being tested
- eVisit
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eVisitOther
electronic surveillance program in lieu of in-person clinic visit
| Study group | Role | What they receive |
|---|---|---|
| eVisit | Experimental | The study intervention will be an electronically performed surveillance program replacing face-to-face clinic follow-up visits. At 3 month intervals for 1 year, the patient will receive an email reminder generated by the patient portal to complete lab testing and eVisit questionnaire. Receives: Other: eVisit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who complete all scheduled eVisits at the end of follow-up
Defined as completion of labwork and at least 80% of the questions asked at each eVisit
Measured: 12 months
Secondary outcomes (8)
Feasibility of enrollment to the eVisit program
Defined as the percentage of patients who are approached for eVisit and ultimately enroll
Measured: 12 months
eVisit participant reported satisfaction
Reported as the summary score from validated Brief Patient Satisfaction 10-item scale instrument assessed from "1/strongly agree" through "5/strongly disagree"
Measured: 12 months
Number of participants with cancer treatment related toxicities
Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities
Measured: 12 months
Number of eVisit participants with cancer recurrence
Defined as biochemical progression (PSA >0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) or metastasis (by imaging)
Measured: 12 months
Financial impact of the eVisit program on participants compared to in person follow up clinic visits
Defined by the financial burden assessment completed by participants, scored from "0/not at all" through "4/very much"
Measured: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Defined by percentage of participants/eVisits covered by insurance
Measured: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Defined by qualitative analysis of time commitment for providers
Measured: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Defined by qualitative analysis of reimbursement process
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study startJun 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Principal Investigator left Duke University
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bridget Koontz, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486846
- Sponsor's protocol ID
- Pro00104751
- Status last verified
- Jun 2021
- First submitted
- 22 Jul 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
- ClinicalTrials.gov ID
- NCT04486846
- Acronym / sponsor ID
- Pro00104751
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left Duke University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 27 Jul 2020 (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 purpose of this single institution pilot study is to determine the feasibility of implementing an eHealth prostate cancer surveillance program through the eVisit electronic medical record patient portal. The investigators will assess patient compliance and satisfaction with eVisit follow up care in lieu of in person clinic visits.
Detailed description
Telehealth offers the opportunity to transform cancer surveillance into a patient-centered effort with shared leadership between patient and oncologist. Peer-to-peer electronic communications can improve the collaboration between oncologist and primary care provider (PCP) as patients transition back to primary care as their primary health provider. The investigators propose to test a patient-centered eHealth surveillance program utilizing novel asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using the electronic medical record's patient portal (eVisit).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eVisit | Experimental | Other: eVisitThe study intervention will be an electronically performed surveillance program replacing face-to-face clinic follow-up visits. At 3 month intervals for 1 year, the patient will receive an email reminder generated by the patient portal to complete lab testing and eVisit questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old with histologically confirmed prostate cancer
- Completed curative intent treatment to the prostate +/- pelvis
- Deemed to be "without evidence of active disease" by treating provider with at least 1 follow up visit 3 or more months after treatment completion
- MyChart account or willingness to open account
- Access to the internet
Key exclusion criteria (2 listed)
- Documented extrapelvic metastases
- PSA meeting definition of recurrence (>0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) and rising with doubling time less than 1 year
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 |
|---|---|---|
| eVisitelectronic surveillance program in lieu of in-person clinic visit | Other | eVisit |
Primary outcome
Proportion of patients who complete all scheduled eVisits at the end of follow-up
Time frame: 12 months
Defined as completion of labwork and at least 80% of the questions asked at each eVisit
8 secondary outcomes
Feasibility of enrollment to the eVisit program
Time frame: 12 months
eVisit participant reported satisfaction
Time frame: 12 months
Number of participants with cancer treatment related toxicities
Time frame: 12 months
Number of eVisit participants with cancer recurrence
Time frame: 12 months
Financial impact of the eVisit program on participants compared to in person follow up clinic visits
Time frame: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Time frame: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Time frame: 12 months
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Bridget Koontz, MD principal investigator
Duke Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eVisit in people with Prostate Cancer, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who complete all scheduled eVisits at the end of follow-up (time frame: 12 months). 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 10 Jun 2021.