NCT03333785

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

September 25, 2017

Last Update Submit

April 27, 2021

Conditions

Communication ResearchBreast CancerProstate CancerColorectal CancerLung CancerProgram, CommunicationRemote Consultation

Keywords

Primary CareOncologyContinuity of careIntegration of careCommunication

Outcome Measures

Primary Outcomes (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

    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)

  • Anxiety

    (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)

  • Depression

    (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)

  • Patient experience of the care process

    (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)

Other Outcomes (1)

  • Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire

    Follow-up 1 = Treatment: 1 month; Survivorship: 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Primary 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.

Behavioral: eOncoNote

Control group

NO INTERVENTION

Primary 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.

Interventions

eOncoNoteBEHAVIORAL

* 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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age,
  • being in one of the following three cancer continuum specific phases:
  • Diagnosis phase: patients referred to the Cancer Assessment Clinic with suspected colorectal, prostate, or lung cancer;
  • Treatment phase: patients receiving adjuvant chemotherapy for early stage breast cancer, or radical or adjuvant radiation therapy for localized prostate cancer;
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36652284DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsColorectal NeoplasmsLung NeoplasmsCommunicationNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Eva Grunfeld, MD, DPhil

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Sharon McGee, MD

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Knowledge Translation Research (OICR); Giblon Professor and Vice-Chair Research (Department of Family & Community Medicine, University of Toronto)

Study Record Dates

First Submitted

September 25, 2017

First Posted

November 7, 2017

Study Start

February 5, 2018

Primary Completion

August 31, 2020

Study Completion

February 17, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)