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Implementing Patients´ Competence in Oral Breast Cancer Therapy (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030728
Recruitment Status : Not yet recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Eli Lilly and Company
Institut für Frauengesundheit GmbH
Information provided by (Responsible Party):
Onco Medical Consult GmbH

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.

Condition or disease
Metastatic Breast Cancer Advanced Breast Cancer

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 212 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Group 1: Standardized coaching arm
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.
Group 2: Coaching according to local practice
Patients in this group receive a patient management according local routine.



Primary Outcome Measures :
  1. (Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms. [ Time Frame: 24 weeks ]
    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 Outcome Measures :
  1. Patient decided interruptions [ Time Frame: 24 weeks ]
    Total time of patient decided interruptions in days during 24 weeks of Abemaciclib therapy in both study arms.

  2. eMSBR [ Time Frame: 24 weeks ]
    The effect of eMSBR after 24 weeks of Abemaciclib therapy.

  3. Quality of life assessed by the FACT-B (Version 4.0) questionnaires. [ Time Frame: 24 weeks ]
    After weeks 2, 6, 12, 18 and 24, quality of Life (QoL) will be assessed by the FACT-B (Version 4.0) questionnaires.

  4. Patient distress assessed via distress thermometer. [ Time Frame: 24 weeks ]
    After weeks 2, 6, 12, 18 and 24, patient distress will be assessed via distress thermometer.

  5. To assess patient reported self-efficacy: patient diary [ Time Frame: 24 weeks ]
    Self-efficacy will be patient reported and surveyed through a patient dairy.

  6. To assess patient reported side-effects. [ Time Frame: 24 weeks ]
    Type and duration of side-effects will be patient reported and surveyed through a patient dairy.

  7. To assess patient reported health related stress. [ Time Frame: 24 weeks ]
    Health related stress will be patient reported and surveyed via distress thermometer questionnaire.

  8. To assess patient reported therapy related knowledge. [ Time Frame: 24 weeks ]
    Therapy related knowledge will be surveyed via MOATT (MASCC Oral Agent Teaching Tool).

  9. Incidence of therapy interruptions. [ Time Frame: 24 weeks ]
    Amount of relevant events will be surveyed through patient self-reporting via patient diary.

  10. Duration of therapy interruptions. [ Time Frame: 24 weeks ]
    Relevant events (in days) will be surveyed through patient self-reporting via patient diary.

  11. Safety and tolerability of Abemaciclib treatment: NCI Common Toxicity Criteria Version 5.0 [ Time Frame: 24 weeks ]
    Incidence of adverse events and serious adverse events will be reported according to NCI Common Toxicity Criteria Version 5.0.

  12. Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Progression free survival rate (PFS). [ Time Frame: 24 weeks ]
    Progression free survival (PFS) rate at 24 weeks of therapy. PFS is defined as time interval from start of therapy until progressive proven with clinical measures according to expertise and daily clinical routine or death from any cause, whichever comes first.

  13. Efficacy between the two study arms at week 24 in routine clinical practice as assessed by Overall survival rate (OS). [ Time Frame: 24 weeks ]
    Overall survival (OS) rate at 24 months is defined as the time to death from therapy start of Abemaciclib.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030728


Contacts
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Contact: Jenny Palmrich 0049 69 560056 182 jenny.palmrich@chop-studien.de
Contact: Oliver Knapp, PhD 0049 931 359200 68 knapp@clin-sol.com

Sponsors and Collaborators
Onco Medical Consult GmbH
Eli Lilly and Company
Institut für Frauengesundheit GmbH
Investigators
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Principal Investigator: Hans Tesch, Prof. Dr. med. Onkologie Bethanien Frankfurt
Principal Investigator: Manfred Welslau, Dr. med. Onkologie Aschaffenburg

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Responsible Party: Onco Medical Consult GmbH
ClinicalTrials.gov Identifier: NCT04030728    
Other Study ID Numbers: OMC2018/01
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Onco Medical Consult GmbH:
patient coaching
Advanced or metastatic breast cancer
Abemaciclib
hormone receptor positive (HR+)
human epidermal growth factor receptor 2 (HER2) negative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs