AzTrials
AzTrials

Communication ResearchNCT03333785

Randomized Trial of eOncoNote

A study testing eOncoNote in people with Communication Research and Breast Cancer, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Improving Cancer Care Together through eOncoNote is a pragmatic randomized trial involving a secure online eConsultation system (referred to as eOncoNote) that will allow primary care providers and cancer specialist providers to communicate about their patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
eOncoNote
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 siteCanada
Study dates
5 Feb 2018to 17 Feb 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Patient inclusion criteria:

  • at least 18 years of age,
  • being in one of the following three cancer continuum specific phases:
  1. Diagnosis phase: patients referred to the Cancer Assessment Clinic with suspected colorectal, prostate, or lung cancer;
  2. Treatment phase: patients receiving adjuvant chemotherapy for early stage breast cancer, or radical or adjuvant radiation therapy for localized prostate cancer;
  3. Survivorship phase: patients referred to the Wellness Beyond Cancer Program post completion of their adjuvant therapy for either breast or colorectal cancer with the intent of being discharged for survivorship care to their own family physician;
  • no prior history of cancer in the past 5 years (those with non-melanoma skin cancer can participate).

Patient exclusion criteria:

  • Currently participating in another study requiring ongoing completion of patient reported outcome measures (such as quality of life measures) in order to minimize respondent burden,
  • Does not have a primary care provider,
  • Patients will be excluded if their primary care provider has another patient enrolled in the trial in order to control for contamination between randomization groups,
  • Inability to read and write in English,
  • Inability to provide informed consent, and
  • In the survivorship phase, patients who are discharged to the Wellness Beyond Cancer Program nurse practitioner (rather than their primary care providers) will be excluded.

Primary care providers eligibility criteria:

  • Licensed family physician or nurse practitioner,
  • Their patient has consented to be enrolled in the study, and they do not have any other patients enrolled in the study (to avoid contamination between intervention and control groups),
  • They are already registered on the Champlain BASE(TM) eConsult system prior to their patient being enrolled in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: Improving Cancer Care Together Through eOncoNote

Improving Cancer Care Together through eOncoNote is a pragmatic randomized trial involving a secure online eConsultation system (referred to as eOncoNote) that will allow primary care providers and cancer specialist providers to communicate about their patients.

Read the detailed description

The overall objectives of this randomized trial are to test an intervention designed to improve coordination/continuity of care between primary care providers (PCPs) and cancer specialist providers (CSPs), and to improve patient experience with regards to patients' perceived continuity of care. Participants will be patients at The Ottawa Hospital Cancer Centre in any one of three phases of the cancer continuum: diagnosis (colorectal, prostate, or lung cancer), active treatment (breast or prostate cancer) or survivorship (breast or colorectal cancer). The intervention involves a secure online eConsultation system that will allow PCPs and CSPs to communicate about their patient. Patients will be randomly allocated to one of two groups: 1) intervention group whereby their PCP and CSP will use a cancer-specific modification of the eConsultation system (eOncoNote) in addition to usual methods of communication or 2) control group receiving usual care (i.e. usual methods of communication such as telephone, fax, mailed consultation letters and progress notes). Randomization and outcomes will be at the level of the individual patient. The primary outcome is patients' perception of team/cross-boundary continuity. Secondary outcomes include measures of patients' anxiety and depression, and patients' experience of the care process. Qualitative methods including interviews with patients, PCPs, CSPs, and cancer system managers will also be conducted.

Being tested
eOncoNote
Keywords
Primary Care, Oncology, Continuity of care, Integration of care, Communication
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Communication, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eOncoNoteBehavioural

    • Diagnosis phase: The patient's nurse navigator will initiate an eOncoNote to the patient's PCP, inviting them to send any questions related to the patient's diagnostic process. The nurse navigator will initiate case closure after the diagnostic process has been completed (case will be open up to 4 months).
    • Treatment phase: The patient's medical or radiation oncologist will initiate an eOncoNote to the patient's PCP inviting them to ask questions related to the patient's cancer treatment and/or request information related to the patient's co-morbidities. The oncologist will initiate case closure after the treatment has been completed.
    • Survivorship phase: The patient's registered nurse within the Wellness Beyond Cancer Program will send an eOncoNote invitation to the patient's PCP inviting them to ask any questions as the patient transitions back to their care. The nurse will initiate case closure after one year.
Study groups in NCT03333785
Study groupRoleWhat they receive
Intervention groupExperimentalPrimary care providers whose patients have been randomized to the intervention group will receive an invitation from their patient's cancer specialist provider to communicate using eOncoNote. Primary care providers and cancer specialist providers will use eOncoNote in addition to usual methods of communication.
Receives: Behavioral: eOncoNote
Control groupNo interventionPrimary care providers whose patients have been randomized to the control group will receive usual care (i.e. their primary care providers will not access eOncoNote to communicate with the cancer specialist providers and vice versa) and will be able to contact each other via telephone, fax, and mail consultation letters and progress notes, as per usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire

    4-item subscale (scored on a five-point scale ranging from 1 = strongly disagree to 5 = strongly agree); calculate the mean of the items in the subscale

    Measured: Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months

Secondary outcomes (3)

  1. Anxiety

    Generalized Anxiety Disorder Screener (GAD-7); 7 items; 4 response options ("not at all" = 0; "several days" = 1; "more than half the days" = 2; "nearly every day" = 3)

    Measured: (Follow-up 1 = Treatment: 1 month; Survivorship: 6 months); (Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months)

  2. Depression

    Patient Health Questionnaire on major depression (PHQ-9); 10 items in total; items 1-9: 4 response options ("not at all" = 0; "several days" = 1; "more than half the days" = 2; "nearly every day" = 3); item 10: four-point scale (ranging from "not difficult at all" to "extremely difficult")

    Measured: (Follow-up 1 = Treatment: 1 month; Survivorship: 6 months); (Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months)

  3. Patient experience of the care process

    Picker Patient Experience Questionnaire (PPE-15); 15 items; each item scored as dichotomous score indicating presence or absence of a problem (defined as an aspect of health care that could be improved upon from the patient's perspective)

    Measured: (Follow-up 1 = Treatment: 1 month; Survivorship: 6 months); (Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start5 Feb 2018
  3. Primary completion31 Aug 2020
  4. Study completion17 Feb 2021

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Improving Cancer Care Together through eOncoNote is a concurrent mixed-methods hybrid type I effectiveness-implementation study design. Effectiveness of eOncoNote will be assessed by a pragmatic randomized controlled trial with individual patient randomization and outcomes measured at the patient level. Implementation will be assessed using a mixed methods process evaluation involving key stakeholders to assess barriers and facilitators to implementation of the intervention.
Masking
None (open label)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03333785
Sponsor's protocol ID
OHSN-REB#20170381-01H
Other IDs
128272
Status last verified
Apr 2021
First submitted
25 Sep 2017
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Petrovic B, Julian JA, Liddy C, Afkham A, McGee SF, Morgan SC, Segal R, Sussman J, Pond GR, O'Brien MA, Bender JL, Grunfeld E. Web-Based Asynchronous Tool to Facilitate Communication Between Primary Care Providers and Cancer Specialists: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2023 Jan 18;25:e40725. doi: 10.2196/40725.

    PubMed 36652284

Questions about this trial

What is this clinical trial studying?

A study testing eOncoNote in people with Communication Research and Breast Cancer, run by University of Toronto 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?

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: finished, as of the sponsor's last update on 29 Apr 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire (time frame: Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03333785, which also lists 1 linked publication.

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 29 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in