Clinical trial NCT04486846: Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
Official title: Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients who complete all scheduled eVisits at the end of follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Feasibility of enrollment to the eVisit program
timeFrame: 12 months
measure: eVisit participant reported satisfaction
timeFrame: 12 months
measure: Number of participants with cancer treatment related toxicities
timeFrame: 12 months
measure: Number of eVisit participants with cancer recurrence
timeFrame: 12 months
measure: Financial impact of the eVisit program on participants compared to in person follow up clinic visits
timeFrame: 12 months
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
timeFrame: 12 months
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
timeFrame: 12 months
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
timeFrame: 12 months
Other outcomes:
Locations:
city: Cary
country: United States
facility: Duke Cancer Institute Cary
state: North Carolina
city: Durham
country: United States
facility: Durham Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
Study officials:
affiliation: Duke Health
name: Bridget Koontz, MD
role: PRINCIPAL_INVESTIGATOR
References: