Back to resultsElectronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eVisit
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Cancer
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
Sites / Locations
- Duke Cancer Institute Cary
- Durham Regional Hospital
- Duke University Medical Center
- Duke Raleigh Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eVisit
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Feasibility of enrollment to the eVisit program
Defined as the percentage of patients who are approached for eVisit and ultimately enroll
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"
Number of participants with cancer treatment related toxicities
Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities
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)
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"
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
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
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Defined by qualitative analysis of reimbursement process
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486846
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left Duke University
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eVisit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eVisit
Intervention Description
electronic surveillance program in lieu of in-person clinic visit
Primary Outcome Measure Information:
Title
Proportion of patients who complete all scheduled eVisits at the end of follow-up
Description
Defined as completion of labwork and at least 80% of the questions asked at each eVisit
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Feasibility of enrollment to the eVisit program
Description
Defined as the percentage of patients who are approached for eVisit and ultimately enroll
Time Frame
12 months
Title
eVisit participant reported satisfaction
Description
Reported as the summary score from validated Brief Patient Satisfaction 10-item scale instrument assessed from "1/strongly agree" through "5/strongly disagree"
Time Frame
12 months
Title
Number of participants with cancer treatment related toxicities
Description
Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities
Time Frame
12 months
Title
Number of eVisit participants with cancer recurrence
Description
Defined as biochemical progression (PSA >0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) or metastasis (by imaging)
Time Frame
12 months
Title
Financial impact of the eVisit program on participants compared to in person follow up clinic visits
Description
Defined by the financial burden assessment completed by participants, scored from "0/not at all" through "4/very much"
Time Frame
12 months
Title
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Description
Defined by percentage of participants/eVisits covered by insurance
Time Frame
12 months
Title
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Description
Defined by qualitative analysis of time commitment for providers
Time Frame
12 months
Title
Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
Description
Defined by qualitative analysis of reimbursement process
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget Koontz, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Institute Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Durham Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)
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