Back to resultsTelemedicine Clinic for Prostate Cancer Patients
Primary Purpose
Cancer, Treatment-Related
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visits conducted via Telemedicine
Sponsored by
About this trial
This is an interventional other trial for Cancer, Treatment-Related
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
-
Sites / Locations
- Grand River HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
OTN virtual clinic
In person Visits
Arm Description
Pharmacist 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.
Patients are followed in person at the cancer clinic based on standard of care guidelines
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03413865
First Posted
January 12, 2018
Last Updated
February 12, 2019
Sponsor
Grand River Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03413865
Brief Title
Telemedicine Clinic for Prostate Cancer Patients
Official Title
A Pilot Study of a Nurse and Pharmacist Led OTN (Ontario Telemedicine Network) Based Clinic for Management of Prostate Cancer Patients on Oral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 28, 2016 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grand River Hospital
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Treatment-Related
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OTN virtual clinic
Arm Type
Experimental
Arm Description
Pharmacist 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.
Arm Title
In person Visits
Arm Type
No Intervention
Arm Description
Patients are followed in person at the cancer clinic based on standard of care guidelines
Intervention Type
Other
Intervention Name(s)
Visits conducted via Telemedicine
Intervention Description
Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse
Primary Outcome Measure Information:
Title
Patient satisfaction with overall care
Description
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
Time Frame
2 Years
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate Cancer Patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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)
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Hubay, MD, FRCPC
Phone
519-749-4370
Ext
2307
Email
stacey.hubay@grhosp.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Girolametto, MA, MHSC
Phone
519-749-4370
Ext
2307
Email
carla.girolametto@grhosp.on.ca
Facility Information:
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Girolametto
Phone
5197494370
Ext
2307
Email
carla.girolametto@grhosp.on.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine Clinic for Prostate Cancer Patients
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