C50
Conditions
Interventions
Group 1: Intervention group: Weekly EQ-VAS surveys with a subsequent intervention algorithm, in addition to the HRQoL surveys linked to the therapy.
Group 2: Control group: baseline visits (PRO, quest
Sponsors
Universitätsklinik und Poliklinik für Gynäkologie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Computer, tablet, or mobile phone with internet access. ? Invasive breast cancer or metastasis of breast cancer and neoadjuvant chemotherapy (NIGHT). ? Capacity to consent. ? Signed informed consent and agreement to the data protection regulations. ? The inclusion criteria for the accompanying feasibility and usability study are identical. However, study staff (e.g., physicians, study nurses, other relevant staff) can also be included.
Exclusion criteria
Exclusion criteria: ? Patients who, according to the treating physician, cannot reasonably be expected to participate in the study due to a severely limited life expectancy or serious comorbidities. ? Patients who, according to the treating physician, are not suitable for informed consent and cooperation due to psychological or cognitive limitations. ? Patients who have not signed the consent form or do not agree to the data protection regulations. ? The exclusion criteria for the accompanying study on feasibility and usability are identical.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in general fatigue from baseline to 14 weeks after therapy start (i.e., 12 weeks / 3 months after intervention start), assessed with the EORTC QLQ-FA12 and operationalised as the mean index of the physical, emotional, and cognitive fatigue subscales. Baseline is defined as 2 weeks after therapy start. The primary confirmatory comparison between intervention and control arm is performed using a two-sided t-test, adjusted for the baseline value. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Health-related quality of life and patient-reported burden during therapy, compared between intervention and control arm at the pre-specified visits (baseline, 1/3, 1/2, 2/3, end of NACT, post-OP), assessed with: • PROMIS-29 (subscales) • EORTC QLQ-C30 (functional and symptom scales) • EORTC QLQ-BR45 (reduced) • PHQ-4 (total score, longitudinal ePOS) • FACT-COG, Perceived Cognitive Abilities subscale (longitudinal ePOS) • FACIT-FinTox (financial toxicity, visits 2 and 6) • Further secondary endpoints: • Relative Dose Intensity (RDI) and Summation Dose Intensity Product at end of NACT (eCRF) • Pathological complete response (pCR) rate at surgery • Time to deterioration (TTD) of adverse events, operationalised via the symptom scales of the EORTC QLQ-C30 • Time to deterioration of HRQoL (PROMIS-29 and EORTC QLQ-C30 subscales) • Patient-centeredness and patient participation, assessed with PSQ-18 (visits 2, 5, 6) and PEF-FB-9 (baseline and visits 2, 5, 6) • Predictive value of the weekly EQ-VAS assessments with respect to the established PROM instruments for TTD of HRQoL (intervention arm) • Usability and feasibility of the application, assessed with the System Usability Scale (SUS, intervention arm, visits 2, 5, 6) Longitudinal HRQoL in relation to treatment adherence indicators (e.g., number of completed EQ-VAS assessments, accessed educational content) Statistical methods for secondary endpoints: mixed-effects regression models with group allocation as fixed effect and baseline value, study centre, age, and tumour biology as covariates; chi-squared tests for categorical comparisons (improved / unchanged / deteriorated HRQoL; pCR rate); Cox proportional hazards models for time-to-event analyses. All estimates are reported with 95 % confidence intervals and interpreted in an exploratory manner. | — |
Countries
Germany
Contacts
Public ContactMarkus Wallwiener
Universitätsklinik und Poliklinik für Gynäkologie
Outcome results
None listed