Cancer, Treatment-RelatedNCT03413865
Telemedicine Clinic for Prostate Cancer Patients
A study testing Visits conducted via Telemedicine in people with Cancer, Treatment-Related, run by Waterloo Regional Health Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cancer, Treatment-Related
- What is being tested?
- Visits conducted via Telemedicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 28 Oct 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Grand River Hospital
Kitchener, Ontario
Carla Girolametto, 5197494370 ext. 2307, carla.girolametto@grhosp.on.ca
About this study
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
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
- Being tested
- Visits conducted via Telemedicine
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visits conducted via TelemedicineOther
Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start28 Oct 2016
- Primary completionOct 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Treatment-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waterloo Regional Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413865
- Sponsor's protocol ID
- OTN Study
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03413865
- Acronym / sponsor ID
- OTN Study
- Conditions
- Cancer, Treatment-Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Waterloo Regional Health NetworkUniversity, hospital or other
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTN virtual clinic | Experimental | Other: Visits conducted via TelemedicinePharmacist 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. |
| In person Visits | No intervention | –Patients are followed in person at the cancer clinic based on standard of care guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visits conducted via TelemedicinePatients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse | Other | OTN virtual clinic |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visits conducted via Telemedicine in people with Cancer, Treatment-Related, run by Waterloo Regional Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacey Hubay, MD, FRCPC (519-749-4370 ext. 2307, stacey.hubay@grhosp.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with overall care (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.