NCT03413865

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

January 12, 2018

Last Update Submit

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

EXPERIMENTAL

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

In person Visits

NO INTERVENTION

Patients 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

OTN virtual clinic

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate Cancer Patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Neoplasms

Central Study Contacts

Stacey Hubay, MD, FRCPC

CONTACT

Carla Girolametto, MA, MHSC

CONTACT

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

Locations