Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)

Prostate Cancer Clinical Trial

Official title:

Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04486846
• Other study ID #: Pro00104751
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: March 2022

Study information

• Verified date: June 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators will assess patient compliance and satisfaction with eVisit follow up care in lieu of in person clinic visits.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• eVisit
electronic surveillance program in lieu of in-person clinic visit

Locations

Country	Name	City	State
United States	Duke Cancer Institute Cary	Cary	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Regional Hospital	Durham	North Carolina
United States	Duke Raleigh Hospital	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Feasibility of enrollment to the eVisit program	Defined as the percentage of patients who are approached for eVisit and ultimately enroll	12 months
Secondary	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"	12 months
Secondary	Number of participants with cancer treatment related toxicities	Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities	12 months
Secondary	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)	12 months
Secondary	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"	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up	Defined by qualitative analysis of reimbursement process	12 months