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Telemedicine Clinic for Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT03413865
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Grand River Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer, Treatment-Related Other: Visits conducted via Telemedicine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of a Nurse and Pharmacist Led OTN (Ontario Telemedicine Network) Based Clinic for Management of Prostate Cancer Patients on Oral Therapy
Actual Study Start Date : October 28, 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Patient satisfaction with overall care [ Time Frame: 2 Years ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Cancer Patients
Accepts Healthy Volunteers:   No
Criteria

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)

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413865


Contacts
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Contact: Stacey Hubay, MD, FRCPC 519-749-4370 ext 2307 stacey.hubay@grhosp.on.ca
Contact: Carla Girolametto, MA, MHSC 519-749-4370 ext 2307 carla.girolametto@grhosp.on.ca

Locations
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Canada, Ontario
Grand River Hospital Recruiting
Kitchener, Ontario, Canada
Contact: Carla Girolametto    5197494370 ext 2307    carla.girolametto@grhosp.on.ca   
Sponsors and Collaborators
Grand River Hospital

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Responsible Party: Grand River Hospital
ClinicalTrials.gov Identifier: NCT03413865     History of Changes
Other Study ID Numbers: OTN Study
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms