The intervention in this study will consist of a web-based portal that leverages the
existing data entry and reporting capacity of the REDCap (Research Electronic Data
Capture) platform to prompt study participants to enter various health-related quality of
life (HRQOL) and symptom measures online at regular intervals throughout the course of
the neoadjuvant/adjuvant systemic therapy, and particularly in between scheduled clinic
visits (per standard of care dependent on chemotherapy protocol). Specifically, the
portal will incorporate the following PROs: the Edmonton Symptom Assessment Scale revised
version (ESASr), the European Organization for Research and Treatment of Cancer - Quality
of Life Questionnaire Cancer Patients (EORTC-QLQ C30), the European Organization for
Research and Treatment of Cancer - Quality of Life Questionnaire Breast Cancer (EORTC-QLQ
BR23), and the European Organization for Research and Treatment of Cancer - Quality of
Life Questionnaire Colorectal Cancer (EORTC-QLQ CR29), and selected adverse event-related
questions related to commonly prescribed neoadjuvant/adjuvant systemic therapy regimens
for breast and colorectal cancer. The portal will identify all study participants who
have entered scores 4 or greater on the ESASr scale and subsequently alert the
participant's research nurse to perform a review of the patient's records and initiate a
telephone assessment with the study participant. The study hypothesizes that patients
experiencing this level of symptom severity are currently accustomed to initiating
contact with the nurse; this is a reactive approach whereby the healthcare team does not
respond unless the patient initiates the contact. The investigators propose a more
proactive approach whereby the healthcare team initiates the contact as symptoms are
reported. By addressing symptoms as they occur, this will most likely reduce the
resources (nursing time, etc.) required to address symptoms as a point when they have
become more severe or need acute intervention.
For participants with mild symptoms (Less than 4 on ESASr), subjects will be prompted by
the online system to refer to standardized patient educational materials on
self-management of symptoms (provided as hyperlinks to online web-based standardized
self-management information. Hyperlinks to standardized educational materials with
instructions on how to manage common symptoms associated with chemotherapy treatment will
also be provided to participants on the intervention arm.
For participants who are identified as having a high burden of symptoms (e.g., a score of
4 or greater on any one symptom), the research nurse will be able to pre-emptively offer
clinical advice by phone on appropriate symptom management, notify the responsible
physician, and provide interventions to alleviate these symptoms as per usual routine. If
needed, the research nurse and physician may offer the participant an unscheduled clinic
visit to manage symptom crises in person. Conversely, for participants with a very low
symptom burden (e.g., all symptom scores less than 4) or no symptoms at all, the portal
will offer these individuals an opportunity to opt-out of the next scheduled face-to-face
clinic visit within 24 hours prior to the scheduled clinic visit. Prior to the opt-out,
the research nurse will also perform a review of the patient's records, conduct a
telephone assessment with the participant to assess symptom levels, and notify the
physician to confirm that cancelling the in-person clinic visit is both safe and
clinically reasonable to pursue. It will ultimately be at the discretion of the treating
oncologist whether or not participants feel comfortable canceling this visit.
Asymptomatic participants will retain the right to keep the scheduled clinic appointment.
All ePROs and their trends over time will be made available at each clinic visit to the
primary cancer nurse and oncologist(s) both electronically and on the paper chart to
further facilitate treatment decision-making and optimize symptom management.