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NCT Number: NCT07521202

IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE

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.

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Key information

Conditions

HR+/HER2- Early Breast Cancer

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology

Erlangen, Bavaria, 91054, Germany

Location contact

Prof. Dr. med. Peter A. Fasching

CONTACT

[email protected]

+4991318533572

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized patient coaching

Behavioral

Standardized patient coaching based on the Multinational Association of Supportive Care in Cancer (MASCC) Oral Agent Teaching Tool© (MOATT)

Primary outcomes

  1. Time to discontinuation

    Time frame: From enrollment until 1 year or time of permanent discontinuation of abemaciclib, which ever comes first

    Time to permanent discontinuation of abemaciclib therapy

Secondary outcomes

  1. Persistence rate

    Time frame: At 6 and 12 months after therapy start

    Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

  2. Satisfaction with Information about Medicines Scale (SIMS-D)

    Time frame: At 6 and 12 months after therapy start

    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.

  3. Medication Adherence Rate Scale (MARS-D)

    Time frame: At 6 and 12 months after therapy start

    A total score ranges from 5 to 25 for adherence with higher scores indicating higher self-treported adherence.

  4. Bloem's patient typology questionnaire

    Time frame: At 6 and 12 months after therapy start

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsor's study office

CONTACT

[email protected]

+49 15739466438

Sponsors and collaborators

Lead sponsor

Institut fuer Frauengesundheit

Other

Collaborators

  • Lilly Deutschland GmbH Germany

Registry information

Official study title

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.

Acronym: IMPACT PT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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