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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03413865
Other study ID # OTN Study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2016
Est. completion date June 2021

Study information

Verified date February 2019
Source Grand River Hospital
Contact Stacey Hubay, MD, FRCPC
Phone 519-749-4370
Email stacey.hubay@grhosp.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date June 2021
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
Visits conducted via Telemedicine
Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse

Locations

Country Name City State
Canada Grand River Hospital Kitchener Ontario

Sponsors (1)

Lead Sponsor Collaborator
Grand River Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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