Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 746
- 主要终点
- The occurrence of any non-hematological side effects grade ≥3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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
结局指标
主要结局
The occurrence of any non-hematological side effects grade ≥3
时间窗: Up to 30 weeks after start chemotherapy
The occurrence of any non-hematological side effects grade ≥3 during neo-adjuvant or adjuvant treatment
次要结局
- Toxicity patterns(Up to 30 weeks after start chemotherapy)
- Unplanned Care(Up to 30 weeks after start chemotherapy)
- Validation of eChemoCoach questionnaires(During the first year of the study)
- Patient experienced stress(on baseline, 10 and 20 weeks after start of chemotherapy)
- Relative dose intensity (RDI)(Up to 30 weeks after start chemotherapy)
- Patient experienced anxiety(on baseline, 10 and 20 weeks after start of chemotherapy)
- HRQOL(on baseline, 10 and 20 weeks after start of chemotherapy)
- Patient empowerment(on baseline, 10 and 20 weeks after start of chemotherapy)
- Usability(After inclusion of all intervention patients)
- Agreement eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs, and the Dutch translation of CTCAE(Up to 30 weeks after start chemotherapy)
研究者
Mathijs Hendriks, MD
Principal investigator
Noordwest Ziekenhuisgroep