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Randomized Trial of eOncoNote

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333785
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : June 1, 2020
Sponsor:
Collaborators:
Ontario Clinical Oncology Group (OCOG)
Ottawa Regional Cancer Centre
Information provided by (Responsible Party):
Eva Grunfeld, University of Toronto

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.

Condition or disease Intervention/treatment Phase
Communication Research Breast Cancer Prostate Cancer Colorectal Cancer Lung Cancer Program, Communication Remote Consultation Behavioral: eOncoNote Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Improving Cancer Care Together Through eOncoNote
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
Experimental: Intervention group
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
  • 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.

No Intervention: Control group
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.



Primary Outcome Measures :
  1. 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 ]
    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


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: (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) ]
    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)

  2. Depression [ Time Frame: (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 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")

  3. Patient experience of the care process [ Time Frame: (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) ]
    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)


Other Outcome Measures:
  1. Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire [ Time Frame: Follow-up 1 = Treatment: 1 month; Survivorship: 6 months ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03333785


Locations
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Canada, Ontario
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
University of Toronto
Ontario Clinical Oncology Group (OCOG)
Ottawa Regional Cancer Centre
Investigators
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Principal Investigator: Eva Grunfeld, MD, DPhil University of Toronto
Principal Investigator: Sharon McGee, MD Ottawa Hospital Research Institute
Additional Information:
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Responsible Party: Eva Grunfeld, Director, Knowledge Translation Research (OICR); Giblon Professor and Vice-Chair Research (Department of Family & Community Medicine, University of Toronto), University of Toronto
ClinicalTrials.gov Identifier: NCT03333785    
Other Study ID Numbers: OHSN-REB#20170381-01H
128272 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
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
Keywords provided by Eva Grunfeld, University of Toronto:
Primary Care
Oncology
Continuity of care
Integration of care
Communication
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases