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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer, Treatment-Related
• Intervention / Treatment: Other: Visits conducted via Telemedicine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Hubay, MD, FRCPC; Phone Number: 2307 519-749-4370; Email: stacey.hubay@grhosp.on.ca
• Study Contact Backup: Name: Carla Girolametto, MA, MHSC; Phone Number: 2307 519-749-4370; Email: carla.girolametto@grhosp.on.ca

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada
      • Recruiting
      • Grand River Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male over 18 years of age with prostate cancer receiving oral treatment with abiraterone or enzalutamide.
2. Ability to provide consent to study.
3. Willingness to complete study questionnaires and a semi-structured exit interview.
4. Adequate command of the English language to complete study questionnaire and survey.
5. Access to technology to allow a link to the virtual telemedicine clinic. (excluding control group)
6. Willingness to participate in videoconference with pharmacist or nurse from their home environment. (excluding control group)

Exclusion Criteria:

1. Patients receiving oral anti-cancer therapy other than abiraterone and enzalutamide.

2. Patients lacking the technology at home to participate in the virtual telemedicine clinic. (excluding control group)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OTN virtual clinic; 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.	Other: Visits conducted via Telemedicine; Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse
NO_INTERVENTION: In person Visits; Patients are followed in person at the cancer clinic based on standard of care guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Grand River Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 28, 2016
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (ACTUAL): January 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: OTN Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No