Implementing Patients´ Competence in Oral Breast Cancer Therapy

NCT04030728 | Unknown DMC

• 1 other identifier: OMC2018/01
• Study Type: observational
• Target: 212
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• (Potential) difference in persistence rate after 24 weeks of Abemaciclib therapy in both study arms.

  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.

  24 weeks

Secondary Outcomes (13)

• Patient decided interruptions

  24 weeks

• eMSBR

  24 weeks

• Quality of life assessed by the FACT-B (Version 4.0) questionnaires.

  24 weeks

• Patient distress assessed via distress thermometer.

  24 weeks

• To assess patient reported self-efficacy: patient diary

  24 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Onco Medical Consult GmbH: lead
• Eli Lilly and Company: collaborator
• Institut fuer Frauengesundheit: collaborator

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hans Tesch, Prof. Dr. med.

  Onkologie Bethanien Frankfurt

  PRINCIPAL INVESTIGATOR

• Manfred Welslau, Dr. med.

  Onkologie Aschaffenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Palmrich

CONTACT

0049 69 560056 182; jenny.palmrich@chop-studien.de

Oliver Knapp, PhD

CONTACT

0049 931 359200 68; knapp@clin-sol.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 24, 2019
• Study Start: March 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01