IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE (IMPACT PT)

A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.

The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.

The main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.

Participants will be asked to answer several questionnaires.

Study Overview

• Status: Not yet recruiting
• Conditions: HR+/HER2- Early Breast Cancer
• Intervention / Treatment: Behavioral: Standardized patient coaching

• Study Type: Interventional
• Enrollment (Estimated): 257
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sponsor's study office; Phone Number: +49 15739466438; Email: studien@ifg-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Department of Obstetrics and Gynaecology
      • Contact: Prof. Dr. med. Peter A. Fasching; Phone Number: +4991318533572; Email: fk-studienzentrale@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women age 18 or older at time of ICF signature
• Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago
• Patients treated with abemaciclib according to the SmPC and each center´s medical practice
• Informed consent given prior to the starting study activities

Exclusion Criteria:

• Women who are pregnant or lactating
• Patients with contraindications against abemaciclib according to the current SmPC
• Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized patient coaching; Patients receive standardized coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)	Behavioral: Standardized patient coaching; Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discontinuation	Time to permanent discontinuation of abemaciclib therapy	From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence rate	Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)	At 6 and 12 months after therapy start
Satisfaction with Information about Medicines Scale (SIMS-D)	This scale assess the patient´s knowledge about their treatment. The total score ranges from 0 to 17, with higher scores indicating a higher degree of overall satisfaction with information received.	At 6 and 12 months after therapy start
Medication Adherence Rate Scale (MARS-D)	A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence.	At 6 and 12 months after therapy start
Bloem's patient typology questionnaire	This 6-item instrument classifies patients into four segments: 1) High Acceptance / High Control (Active/Adjusted): Good mental, low care need. 2) Low Acceptance / High Control (Struggling/Active): High need for support to accept the situation. 3) High Acceptance / Low Control (Resigned/Passive): High need for educational/proactive support. 4) Low Acceptance / Low Control (Vulnerable/Anxious): Highest care need, requires intense supportive care.	At 6 and 12 months after therapy start

Collaborators and Investigators

• Sponsor: Institut fuer Frauengesundheit
• Collaborators: Lilly Deutschland GmbH Germany
• Investigators: Study Chair: Peter A. Fasching, Prof. Dr. med., Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IFG-01-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No