Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

Trial Title: Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

NCT ID: NCT06424054

Condition: Breast Cancer
eHealth
Symptom Monitoring
Self Management

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
remote monitoring
emonitoring
eHealth
symptom management
symptom monitoring

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: A clinical randomized controlled trial will be performed in 746 breast cancer patients treated with (neo-)adjuvant chemotherapy. Patients will be randomized to the intervention group, using the eChemoCoach in addition to standard of care monitoring to manage side effects or are randomized to solely standard of care monitoring.

Primary purpose: Prevention

Masking: None (Open Label)

Masking description: This is a open label study since blinding is not possible as healthcare professionals will receive the CTC gradation based on the reported side effects in the intervention group and are obligated to act on these reports.

Intervention:

Intervention type: Other
Intervention name: eChemoCoach
Description: the eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition.
Arm group label: eChemoCoach Group

Summary: Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.

Detailed description: Problem description: The aim of (neo)adjuvant chemotherapy is to increase survival. Therefore, treatment adherence is important. However, patients may experience treatment-related side-effects. In current practice, clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled. Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity, increase treatment adherence and reduce the decline in quality of life. Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity. Therefore, patients should receive a direct advice when experiencing side-effects. However, without interference of a health care professional, this is not possible in standard care. Solution / research direction: There is increasing evidence that incorporating patient reported outcomes (PROs) in clinical care enhances symptom monitoring in cancer patients. Therefore, it is desirable to develop and investigate an electronic smart-phrased side-effects questionnaire which: 1) delivers a real-time personalized advice to the patient, based on CTCAE grading, after the questionnaire is completed and 2) is accessible for patients using an electronic health portal (EHP) of the electronic health record (EHR) to integrate the PRO data into the EHR. Aim / hypothesis: To investigate the effect of adding weekly EHP-mediated monitoring of chemotherapy related side-effects based on CTCAE grading using smart-phrased electronic PRO side-effects questionnaires to standard of care monitoring of side-effects, on the occurrence of CTCAE >= grade 3 toxicity. Plan of investigation: To conduct a pilot study to validate the smart-phrased ePRO side-effects questionnaire. Thereafter, a multicenter clinical randomized trial will start where patients with breast cancer qualifying for (neo)adjuvant chemo(immune)therapy will be randomized to real-time EHP-mediated monitoring of side-effects using a novel smart-phrased ePRO side-effects questionnaire in addition to standard of care monitoring, or to standard of care monitoring solely. Primary objective is the overall rate of CTC grade >=3 non hematological toxicity between both arms. Secondary objectives include relative dose intensity, health-related quality of life, experienced distress, the number of unplanned health care usage and costs. Expected outcome: The investigators hypothesize that adding weekly EHP-mediated monitoring of side-effects using ePRO side-effects questionnaires will significantly lower the occurrence rate of CTCAE grade >=3 non-hematological toxicities.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - - Starting (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment protocols: - Four cycles of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) dose dense q 2 weeks, followed by twelve cycles of weekly paclitaxel 80mg/m2 (also in combination with carboplatin AUC6 q 3 weeks) - Nine cycles q 3 weeks of paclitaxel 80mg/m2 on day 1 and 8, carboplatin AUC 3 on day 1 and 8, trastuzumab 8mg/kg loading dose (followed by doses of 6mg/m2 at subsequent cycles) on day1 and pertuzumab loading dose of 840mg (followed by doses of 420mg at subsequent cycles) on day 1 - Age ≥ 18 years - WHO PS ≤1 - Capable of using the EHP or get help in case of low (e-)health literacy. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person - Being able to read or get help from a relative in case of illiteracy Exclusion Criteria: - - Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies). - Patients who have been treated with chemotherapy in the past (since these patients are at higher risk for developing side effects of current chemotherapy). - Patients that already started with their chemotherapy cycle

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 1, 2025

Completion date: December 1, 2029

Lead sponsor:
Agency: Noordwest Ziekenhuisgroep
Agency class: Other

Collaborator:
Agency: Comprehensive Cancer Centre The Netherlands
Agency class: Other

Collaborator:
Agency: University of Twente
Agency class: Other

Collaborator:
Agency: Dutch Cancer Society
Agency class: Other

Collaborator:
Agency: Borstkanker Onderzoek Groep
Agency class: Other

Source: Noordwest Ziekenhuisgroep

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06424054