Telemedicine Clinic for Prostate Cancer Patients
A Pilot Study of a Nurse and Pharmacist Led OTN (Ontario Telemedicine Network) Based Clinic for Management of Prostate Cancer Patients on Oral Therapy
1 other identifier
interventional
80
1 country
1
Brief Summary
This randomized, open label study will evaluate a nurse and pharmacist led clinic conducted remotely from Grand River Regional Cancer Centre at Grand River Hospital (GRRCC/GRH) using OTN teleconferencing as a platform for patients with prostate cancer receiving oral chemotherapy agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 15, 2019
February 1, 2019
3.9 years
January 12, 2018
February 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Patient satisfaction with overall care
The primary outcome will be a comparison of patient satisfaction with overall care utilizing a validated scale between the group of patients using the OTN clinic and a group of control patients receiving conventional care at GRRCC
2 Years
Study Arms (2)
OTN virtual clinic
EXPERIMENTALPharmacist and nurse led OTN based remote teleconference based clinic (OTN) The OTN clinic will be conducted by providing the patient with a link via email which will allow the patient to access OTN teleconferencing and meet virtually with a pharmacist and nurse during a previously scheduled appointment. Virtual clinic appointments will be 30 minutes long and will consist of a patient assessment and open ended questions about the patient health status using a modified version of the validated MOATT (MASCC Oral Agent Teaching Tool) created by the Multidisciplinary Association of Supportive Care in Cancer.
In person Visits
NO INTERVENTIONPatients are followed in person at the cancer clinic based on standard of care guidelines
Interventions
Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse
Eligibility Criteria
You may qualify if:
- Male over 18 years of age with prostate cancer receiving oral treatment with abiraterone or enzalutamide.
- Ability to provide consent to study.
- Willingness to complete study questionnaires and a semi-structured exit interview.
- Adequate command of the English language to complete study questionnaire and survey.
- Access to technology to allow a link to the virtual telemedicine clinic. (excluding control group)
- Willingness to participate in videoconference with pharmacist or nurse from their home environment. (excluding control group)
You may not qualify if:
- Patients receiving oral anti-cancer therapy other than abiraterone and enzalutamide.
- Patients lacking the technology at home to participate in the virtual telemedicine clinic. (excluding control group)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Grand River Hospital
Kitchener, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2018
First Posted
January 29, 2018
Study Start
October 28, 2016
Primary Completion
October 1, 2020
Study Completion
June 1, 2021
Last Updated
February 15, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share