An interventional study of eOncoNote in Communication Research, Breast Cancer and Prostate Cancer, sponsored by University of Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by University of Toronto · Not applicable, Interventional, and Health services research
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 181 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Toronto is the lead sponsor of 403 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient inclusion criteria:
being in one of the following three cancer continuum specific phases:
Patient exclusion criteria:
Primary care providers eligibility criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
* 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.
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
Time frame: Follow-up 2 = Diagnosis: 2 weeks; Treatment: 4 months for prostate cancer patients, 6 months for breast cancer patients; Survivorship: 12 months
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)
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)
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")
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 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)
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)
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
Time frame: Follow-up 1 = Treatment: 1 month; Survivorship: 6 months
Plan to share: No
Ran from Feb 2018 to primary completion in Aug 2020, 30 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 30 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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