Clinical trial NCT03333785: Randomized Trial of eOncoNote
Official title: Improving Cancer Care Together Through eOncoNote
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication Research
Breast Cancer
Prostate Cancer
Colorectal Cancer
Lung Cancer
Program, Communication
Remote Consultation
Keywords: Primary Care
Oncology
Continuity of care
Integration of care
Communication
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Clinical Oncology Group (OCOG)
name: Ottawa Regional Cancer Centre
First posted: 2017-11-07
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire
timeFrame: Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months
Secondary outcomes:
measure: Anxiety
timeFrame: (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)
measure: Depression
timeFrame: (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)
measure: Patient experience of the care process
timeFrame: (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:
measure: Team/Cross Boundary Continuity subscale of the Nijmegen Continuity Questionnaire
timeFrame: Follow-up 1 = Treatment: 1 month; Survivorship: 6 months
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: University of Toronto
name: Eva Grunfeld, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Sharon McGee, MD
role: PRINCIPAL_INVESTIGATOR
References: