Ignite Creation Date:
2024-05-06 @ 1:28 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04030728
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-07-04
Brief Title:
Implementing Patients Competence in Oral Breast Cancer Therapy
Sponsor:
Onco Medical Consult GmbH
Organization:
Onco Medical Consult GmbH
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT
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 18000 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 CDK46 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 CDK46 inhibitors provide an attractive approach to this kind of treatment and use of oral treatments is increasing Currently there are three CDK46 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 patients 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 patients needs to be empowered to become an expert of hisher 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 ie glutamate GABA and neuromodulators ie 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
However every year about 18000 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 CDK46 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 CDK46 inhibitors provide an attractive approach to this kind of treatment and use of oral treatments is increasing Currently there are three CDK46 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 patients 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 patients needs to be empowered to become an expert of hisher 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 ie glutamate GABA and neuromodulators ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None