Breast Cancer Clinical Trial
— eChemoCoachOfficial title:
Mitigating Toxicity of (Neo)Adjuvant Chemotherapy by Applying Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects: the Prospective Randomized eChemoCoach Trial
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.
Status | Not yet recruiting |
Enrollment | 746 |
Est. completion date | December 1, 2029 |
Est. primary completion date | June 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Noordwest Ziekenhuisgroep | Borstkanker Onderzoek Groep, Comprehensive Cancer Centre The Netherlands, Dutch Cancer Society, University of Twente |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The occurrence of any non-hematological side effects grade =3 | The occurrence of any non-hematological side effects grade =3 during neo-adjuvant or adjuvant treatment | Up to 30 weeks after start chemotherapy | |
Secondary | Toxicity patterns | Time to occurrence of both grade 2 and grade =3 toxicity will be analyzed with a Kaplan-Meier curves.
Occurrence of grade 2 side effects during (neo)adjuvant will be presented as numbers with percentages for patients in both study groups. |
Up to 30 weeks after start chemotherapy | |
Secondary | Relative dose intensity (RDI) | For analyzing the RDI, the RDI will be calculated for each chemotherapeutic agent and presented as mean with standard deviations (SD) (for a description of calculation of the RDI see the objective section paragraph 2.0). The RDI will be calculated per cycle. The RDI will be compared between the intervention and the control group. | Up to 30 weeks after start chemotherapy | |
Secondary | HRQOL | Health-related quality of life measured by the Quality of Life Questionnaire (QLQ-C30s). Scale is ranging from 1 to 4. 1 = not at all, 4 = very much. Higher scores mean a worse QOL. | on baseline, 10 and 20 weeks after start of chemotherapy | |
Secondary | Patient experienced anxiety | Patient experienced anxiety measured using the Hospital Anxiety and Depression Scale. Scale is ranging from 0 to 3. 0 = often, 3 = never. Higher scores means a less worse Hads score. | on baseline, 10 and 20 weeks after start of chemotherapy | |
Secondary | Patient empowerment | Patient empowerment using Patient Activation Measure (PAM13) questionnaire. Ranging from 0 to 3. 0 = I do not agree, 3= I totally agree. A lower score is worse. | on baseline, 10 and 20 weeks after start of chemotherapy | |
Secondary | Patient experienced stress | Patient experienced stress using a distress thermometer. Ranging from 0 to 10 per problem. 0 = no problem, 10 = worst. A higher score means more stress. | on baseline, 10 and 20 weeks after start of chemotherapy | |
Secondary | Unplanned Care | The amount of unplanned hospital care will be presented as median (IQR) and will be analyzed by comparing the number of admissions, unplanned visits, days of hospital admissions between the intervention and control group using Poisson regression analysis. | Up to 30 weeks after start chemotherapy | |
Secondary | Validation of eChemoCoach questionnaires | Cognitive interviews will be analyzed with thematic content analysis. Agreement between professional triage estimations and eChemoCoach will be quantified using Cohen's Kappa coefficient. A semi qualitative assessment will be conducted, comparing the patient-reported adverse effects using eChemoCoach with medical professionals' CTCAE severity assessments. Interviews will be analyzed with thematic content analysis. | During the first year of the study | |
Secondary | Usability | The System Usability Scale will be used for global assessment of the eChemoCoach. usability. Usability will also be assessed by healthcare professionals from participating. sites. The SUS is a 10 item questionnaire with 5 response options. Ranging from strongly disagree to strongly agree. The average SUS score from all 500 studies is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average. | After inclusion of all intervention patients | |
Secondary | Agreement eChemoCoach-reported grades and those reported by PRO-CTCAE, HCPs, and the Dutch translation of CTCAE | To assess the concordance among eChemoCoach-reported grades, PRO-CTCAE, and CTCAEs graded by healthcare professionals (HCPs), we employ the eChemoCoach platform for patient experienced symptom data collection. Each questionnaire administered includes the eChemoCoach and the PRO-CTCAE questionnaire, facilitating immediate and direct comparison of both outcomes. HCPs will document symptom grading in patient files using standardized CTCAE forms. HCPs will grade the severity on pre-planned checks (standard of care) and when necessary in case of severe side effects. | Up to 30 weeks after start chemotherapy |
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