Clinical trial · Observational

Implementing Patients´ Competence in Oral Breast Cancer Therapy

A Randomized, Controlled Study of Standardized Patient Coaching Versus Patient Management According to Local Practice for Patients With Hormone Receptor Positive HER2 Negative Metastatic Breast Cancer Treated With Abemaciclib

NCT04030728CI-TRIAL-00043198IMPACTunknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The aim of the IMPACT - Implementing Patients' competence in oral breast cancer therapy - study is to evaluate the effectiveness of a standardized patient education and coaching and optional eMBSR for therapy management provided by specially trained oncology nurses regarding persistence rate, side effects management and unplanned therapy interruptions in outpatient oncology care for patients under Abemaciclib treatment.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Metastatic Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
Group 1: Standardized coaching arm
description
Patients in this group receive a continuous standardized MOATT based patient education and coaching and optional eMBSR (electronic Mindfulness-Based Stress Reduction) within the first 24 weeks of Abemaciclib treatment.
label
Group 2: Coaching according to local practice
description
Patients in this group receive a patient management according local routine.

Primary outcomes (1)

measure
(Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms.
timeFrame
24 weeks
description
The primary objective of this study is to evaluate both study arms regarding the (potential) effect of patient management according to local routine versus continuous standardized patient education and coaching using the MOATT on persistence rate within the first 24 weeks of Abemaciclib treatment.

Secondary outcomes (13)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Adult breast cancer patients (age ≥18 years).
* Patients with HR+, HER2- advanced or metastatic breast cancer proven by clinical measures (i. e. standard imaging) whose disease has progressed after hormonal therapy in combination with fulvestrant, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy (advanced disease must not be amenable to resection with curative intent).
* Patients treated with Abemaciclib according to the SmPC and each center´s medical practice.
* Informed consent prior to onset of documentation.

Exclusion Criteria:

* Patients with serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
* Females who are pregnant or lactating.
* Patients with active bacterial infections (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment.
* Patients with a personal history in the past 5 years of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
* Patients with contraindications against Abemaciclib according to respective SmPC´s.
* Patients who are not eligible for observation due to severe comorbidities other then mentioned above or unavailability according to the treating physician.

References

Publications (25)

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