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

NCT04486846 | Withdrawn DMC

• 1 other identifier: Pro00104751
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Feasibility of enrollment to the eVisit program

  12 months

• eVisit participant reported satisfaction

  12 months

• Number of participants with cancer treatment related toxicities

  12 months

• Number of eVisit participants with cancer recurrence

  12 months

• Financial impact of the eVisit program on participants compared to in person follow up clinic visits

  12 months

Study Arms (1)

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.

Other: eVisit

Interventions

eVisit OTHER

electronic surveillance program in lieu of in-person clinic visit

eVisit

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (4)

Duke Cancer Institute Cary

Cary, North Carolina, 27518, United States

Location

Durham Regional Hospital

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bridget Koontz, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)