eChemoCoach

BOOG 2024-02

General Information

BOOG number

BOOG 2024-02

Nickname

eChemoCoach

Status

Date: 30/06/2025

Full title

Managing toxicity of (neo)adjuvant chemotherapy by applying electronic health portal-mediated monitoring and coaching of patient-reported side effects: a prospective randomized trial

Indication

Description

E-monitoring of patient reported side effects

Target sample size

746

Estimated study completion date

01/06/2029

Contact

Sponsor

Northwest Clinics, Alkmaar, the Netherlands

Principal Investigator(s)

Dr. Mathijs Hendriks (Northwest Clinics)

Prof. dr. Sabine Siesling (IKNL/University of Twente)

Dr. Corina van den Hurk (Santeon hospitals)

 

Study manager

Dr. Manon Hanrath-Komen (Northwest Clinics)

E: echemocoach@nwz.nl

 

Dr. Elise van Leeuwen-Stok (Clinical Study Manager BOOG)

Ilse Schilderinck, MSc (project assistant BOOG)

E: info@boogstudycenter.nl

Study coordinator

Drs. Rubin Verduin (Northwest Clinics)

E: echemocoach@nwz.nl

Central datamanagement and registration

IKNL

Monitoring

IKNL

Funding

Dutch Cancer society (Dutch: KWF Kankerbestrijding)

Design

The chosen research design for this study is a clinical prospective open-label 1:1 stratified randomized controlled intervention trial.

 

 

 

 

Objectives

Primary objective:

To assess the effect of EHP-mediated monitoring and coaching via the eChemoCoach, in addition to usual care, on the occurrence of non-hematological side effects graded CTCAE ≥3 in breast cancer patients receiving neo-adjuvant or adjuvant chemotherapy.

 

Secondary objectives:

To determine the effect of applying EHP-mediated monitoring and coaching of patient reported side effects compared to standard of care on:

  1. Patterns of toxicity.
  2. The ratio of relative dose intensity (RDI) delivered in patients versus dose intensity recommended by guideline.
  3. Health-related quality of life measured by the Quality of Life Questionnaire (QLQ-C30s).
  4. Patient experienced anxiety measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
  5. Patient experienced stress using a distress thermometer.
  6. Patient empowerment using Patient Activation Measure (PAM13) questionnaire.
  7. Occurrence of unplanned out-patient visits and hospital admissions.

 

Further secondary objectives:

  1. To evaluate the feasibility of implementing the eChemoCoach in clinical settings (e.g. other hospitals).
  2. To compare the side effect evaluation via the eChemoCoach to that of HCPs.
  3. To evaluate the level of concordance between eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs reported severity, as well as comparing PRO-CTCAE outcomes directly with HCPs reported CTCAE grades.
  4. To investigate the usability of the eChemoCoach as experienced by patients and caregivers using the System Usability Scale (SUS).

Endpoints

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.

Eligibility Criteria

Inclusion criteria:

  • Planned to start (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment guidelines:
    • Four cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) dose dense q 2 weeks (ddAC), followed by twelve cycles of weekly paclitaxel 80mg/m2 whether or not combined with four cysles of carboplatin AUC6 q 3 weeks and four cysles of Pembrolizumab 400mg q 6 weeks (for HER2 negative breast cancer); or vice versa (first paclitaxel with or withour carboplatin followed by ddAC)
    • Six to nine (depending on radiologic complete response / local policy) three-weekly cycles of paclitaxel (80 mg/m2 on day 1 and 8), carboplatin (AUC 6 day 1, or AUC 3 on day 1 and 8) , trastuzumab (loading dose of 8 mg/kg on day 1 followed by a 6 mg/m2 dose at subsequent cycles) and pertuzumab (loading dose of 840 mg on day 1 followed by doses of 420 mg at subsequent cycles) for HER2 positive breast cancer
  • Age ≥18 years
  • WHO PS 0 or 1
  • Capable of using the EHP of their hospital. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person, and having access to a computer, tablet, or smartphone.

 

Exclusion criteria:

  • Simultaneously participation in a trial with an investigational product
  • Patients who have been treated with chemotherapy in the past
  • Illiteracy or insufficient understanding of the Dutch language

Regulatory Information

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