IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE

N/ANot Yet RecruitingNCT07521202

Institut fuer Frauengesundheit257 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

257

Conditions

HR+/HER2- Early Breast Cancer

Interventions

Standardized patient coachingBEHAVIORAL

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynaecology

Erlangen, Bavaria, Germany

Outcomes

Primary Outcomes

Time to discontinuation

Time to permanent discontinuation of abemaciclib therapy

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

Secondary Outcomes

Persistence rate

Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At 6 and 12 months after therapy start

Central Contacts

Sponsor's study office

CONTACT

+49 15739466438 studien@ifg-erlangen.de

Data from ClinicalTrials.gov

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