Recruiting

Observational Study

Sponsor:

Grand River Hospital

Code:

NCT03413865

Conditions

Cancer, Treatment-Related

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visits conducted via Telemedicine

Study Details

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.

Conditions

Cancer, Treatment-Related

Study ID

NCT03413865

Start date

Oct 28, 2016

Status verified date

Feb, 2019

Completion date

Jun, 2021

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

no intervention: In person Visits

Patients are followed in person at the cancer clinic based on standard of care guidelines

Interventions

Visits conducted via Telemedicine

Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse

Primary outcome measure

  • Patient satisfaction with overall care [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Stacey Hubay, MD, FRCPC

519-749-4370stacey.hubay@grhosp.on.ca

Carla Girolametto, MA, MHSC

519-749-4370carla.girolametto@grhosp.on.ca

Locations

Grand River Hospital

Recruiting

Kitchener, Ontario, Canada

Contacts

Carla Girolametto

5197494370carla.girolametto@grhosp.on.ca

More Information

Sponsor

Grand River Hospital

Last update posted

Feb 15, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Grand River Hospital on 2019-02-15.