eChemoCoach

Primary endpoint:

The occurrence of non-hematological grade ≥3 side effects, as defined by the CTCAE version 5.0 criteria (see appendix A) during (neo) adjuvant chemotherapy in breast cancer patients.

Secondary endpoints:

To study the effect of EHP-mediated monitoring and coaching with the eChemoCoach on

• Patterns of toxicity: This includes the occurrence of grade 2 side effects during (neo)adjuvant treatment, time to occurrence of both grade 2 and grade ≥ 3 toxicity.
• Relative dose intensity (RDI): will be calculated for each chemotherapeutic agent, including trastuzumab and pertuzumab immunotherapy, by dividing the administered dose by the body surface area and interval in weeks for each cycle. RDI for a single chemotherapeutic agent will calculated by averaging the dose intervals for each cycle and dividing this by standard (optimal) dose interval. RDI for chemotherapeutic regimen in total will be determined by calculating the unweighted average of the RDI’s of the single agents. These RDI’s will be calculated with and without immunotherapy.
• Health Related Quality of Life (HRQOL): This will be measured using the EORTC QLQ-C30 questionnaire. It is designed with a 4-point Likert scale and two questions with a 7-point Likert scale. Overall scale scores are calculated on a range from 0 to 100, with higher scores indicating a better quality of life.
• Experienced anxiety: This will be measured by the Hospital Anxiety and Depression Scale (HADS). The HADS is used to measure anxiety and depression levels. It consists of 14 items, divided into two subscales of seven items each. The total score for each subscale ranges from 0 to 21. A score of ≤7 indicates no depression or anxiety, a score of 8–10 indicates minor depression/anxiety, a score of 11–15 indicates moderate depression/anxiety, and a score of ≥16 indicates severe depression/anxiety.
• Experienced stress during treatment using the distress thermometer (in Dutch “lastmeter”). It consists of a single-item scale where individuals rate their distress on a scale from 0 to 10, with 0 indicating no distress and 10 indicating extreme distress. A score of ≤3 suggests low distress, a score of 4–6 indicates moderate distress, and a score of ≥7 indicates high distress.
• Experienced patient empowerment: This will be measured by the PAM-13 questionnaire. It consists of 13 items, each rated on a four-point scale from strongly disagree to strongly agree. The overall score ranges from 0 to 100, reflecting the respondent’s level of activation. Higher scores indicate higher activation, which means the person is more proactive and competent in managing their health.
• Unplanned hospital care: this includes unplanned hospital admission (with reason of admission), the amount of days of admission, presentations at the emergency department (with reason for presentations) and unplanned outpatient clinic visits.

Further endpoints:

• Feasibility of the implementation of the eChemoCoach in clinical settings (e.g. other participating hospitals).
• The identification of the nature and causes of potential discrepancies observed between toxicity grades scored via the eChemoCoach and that scored by HCP (via qualitative interviews).
• The concordance between eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs, and the Dutch translation of CTCAE, as well as comparing PRO-CTCAE outcomes directly with HCPs reported CTCAE grades.
• The usability of the EHP as experienced by patients and the usability of the side effect display dashboard for caregivers will be measured using the SUS. The SUS consists of ten statements, each rated on a five-point Likert scale ranging from strongly disagree to strongly agree. Scores range from 0 to 100. A score above 68 is generally considered above average, while scores below 68 indicate below-average usability.