Clinical trial NCT04030728: Implementing Patients´ Competence in Oral Breast Cancer Therapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Advanced Breast Cancer
Keywords: patient coaching
Advanced or metastatic breast cancer
Abemaciclib
hormone receptor positive (HR+)
human epidermal growth factor receptor 2 (HER2) negative
Lead sponsor: Onco Medical Consult GmbH
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: Institut fuer Frauengesundheit
First posted: 2019-07-24
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who suffer from HR+, HER2- advanced or metastatic breast cancer treated with with orally administered commercially available, prescribed Abemaciclib in combination with an aromase inhibitor or fulvestrant as initial endocrine-based therapy or in women who have received prior endocrine therapy, thereby reflecting the current SmPC (Fachinformation Verzenios®). All treatments are prescribed and performed according to each center's medical practice. Any treatment choice or change in regimen is performed at the discretion of each treating physician.

Brief summary: 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.

Detailed description: Breast cancer therapy has advanced by far over the last decade. Introduction of novel therapies as well as the introduction of mammography screening are thought to have reduced mortality over the last decade. More women are treated on an individual basis, trying to avoid toxic and non-effective therapies.

However, every year about 18.000 women are diagnosed with metastastic breast cancer in Germany. Breast cancer remains one of the main reasons for deaths among women and is the main reason for death due to cancer in younger women.

Once a tumor is metastasized, well balanced treatment decisions have to be made to take both into consideration, a high chance of tumor control and a low risk for side effects. Especially in the metastatic setting symptom control and quality of life need to be in the focus of the therapy and patient care.

Modern anticancer strategies are designed against specific molecular targets with the goal of sparing normal, non-neoplastic tissues. Choosing specific molecular targets, however, is problematic. CDK4/6 (Cyclin dependent kinase 4 and 6) are important candidate targets for therapeutic intervention.

Traditionally, anticancer therapy has been dominated by intravenous drug therapy. However, oral agents, like CDK4/6 inhibitors, provide an attractive approach to this kind of treatment and use of oral treatments is increasing. Currently, there are three CDK4/6 inhibitors that have reached clinical practice in the management of ER+ HER2- advanced disease. One of them is Ademaciclib which is approved in the US since September 2017 for "adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones".

Oral agents for cancer treatment are increasingly prescribed due to their benefits. However, this type of therapy requires a high level of self-management competence by the patient. A standardized patient education provided by physicians and oncology nurses may influence the handling of the oral agents in a positive way regarding side effects and unplanned therapy interruptions.

When it comes to oral agents, the place of treatment is the patients' home. In this treatment setting, correct treatment management cannot be utilized without identifying a patient's needs to be empowered to become an expert of his/her treatment because cancer therapies are commonly difficult to handle and the medication often shows a high risk of side effects and interactions with other drugs. Care providers are challenged by the question of how mostly elderly and multimorbid patients and their supporting relatives can be enabled with essential competencies to manage their treatment by themselves. Before patients start their cancer therapy, they are usually provided with information about the treatment by their physician. However, patients often feel overwhelmed by all the details in this stressful situation and tend to have a reduced capacity to assimilate complex information. Education and additional support at the beginning and in the course of the treatment can be a useful approach for patients to better handle this situation.

Recent studies showed the positive impact of supportive care programs on patients provided by nurses. Patient-focused motivation techniques and education performed by nurses are suitable to strengthen the patients' understanding of risks and benefits from the anti-cancer treatment and oral agents. These care programs can prevent an incorrect medication intake due to misunderstandings, lead to a decrease of treatment-related symptoms like pain and fatigue and reduce critical events. In addition, patient education can facilitate supportive care through a better communication between patient and health care provider and may advance the early detection of adverse toxicity events and foster rapid symptom management.

Mindfulness based stress reduction (MBSR) shows a positive effect on mental health in breast cancer patients. The evidence confirms that MBSR reduces anxiety, depressiveness and stress of breast cancer patients and increases the health-related quality of life. A key ingredient to reduce the damaging effects of chronic stress, reducing distress, and improving quality of life is to have patients engage in behaviors that decrease sympathetic and increase parasympathetic arousal. Studies show that MBSR have a positive effect on many systems in our body and create fundamental changes in the way the brain functions. MBSR can affect neurotransmitters (i.e. glutamate, GABA) and neuromodulators (i.e. dopamine, serotonin, epinephrine), which are essential in maintaining a healthy balance between sympathetic and parasympathetic arousal, therefore, helping to manage the stress response.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: (Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms.
timeFrame: 24 weeks
Secondary outcomes:
measure: Patient decided interruptions
timeFrame: 24 weeks
measure: eMSBR
timeFrame: 24 weeks
measure: Quality of life assessed by the FACT-B (Version 4.0) questionnaires.
timeFrame: 24 weeks
measure: Patient distress assessed via distress thermometer.
timeFrame: 24 weeks
measure: To assess patient reported self-efficacy: patient diary
timeFrame: 24 weeks
measure: To assess patient reported side-effects.
timeFrame: 24 weeks
measure: To assess patient reported health related stress.
timeFrame: 24 weeks
measure: To assess patient reported therapy related knowledge.
timeFrame: 24 weeks
measure: Incidence of therapy interruptions.
timeFrame: 24 weeks
measure: Duration of therapy interruptions.
timeFrame: 24 weeks
measure: Safety and tolerability of Abemaciclib treatment: NCI Common Toxicity Criteria Version 5.0
timeFrame: 24 weeks
measure: Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Progression free survival rate (PFS).
timeFrame: 24 weeks
measure: Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Overall survival rate (OS).
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Onkologie Bethanien Frankfurt
name: Hans Tesch, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologie Aschaffenburg
name: Manfred Welslau, Dr. med.
role: PRINCIPAL_INVESTIGATOR
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