Telemedicine Clinic for Prostate Cancer Patients

NCT ID: NCT03413865

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-28

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer, Treatment-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Visits conducted via Telemedicine

Intervention Type OTHER

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

In person Visits

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visits conducted via Telemedicine

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

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Grand River Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grand River Hospital

Kitchener, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Stacey Hubay, MD, FRCPC

Role: CONTACT

519-749-4370 ext. 2307

Carla Girolametto, MA, MHSC

Role: CONTACT

519-749-4370 ext. 2307

Facility Contacts

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Carla Girolametto

Role: primary

5197494370 ext. 2307

Other Identifiers

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OTN Study

Identifier Type: -

Identifier Source: org_study_id

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