Evaluating the Effectiveness of Typology-based Coaching on Patients' Therapy Management

NCT07708571 | Recruiting DMC

• 2 other identifiers: IFG-01-20242024-520290-12-00
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate the effect of patient education and patient typology-based coaching on therapy persistence in breast cancer patients taking ribociclib. Researchers will compare the time to permanent treatment discontinuation of patients receiving personalized coaching to the time to permanent treatment discontinuation of patients who only receive standard of care education and counselling, to see if adherence to treatment can be improved by personalized patient coaching.

Conditions

HR+/HER2- Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to discontinuation

  Time to permanent discontinuation of ribociclib therapy

  From baseline up to end of study (max. 5 years)

Secondary Outcomes (1)

• Ribociclib persistence rate

  At 6, 12 and 36 months after therapy start

Study Arms (2)

Typology-based coaching

EXPERIMENTAL

Personalized therapy coaching based on patient typology

Behavioral: Typology-based coaching

Standard of care patient counselling

NO INTERVENTION

Standard of care therapy education and counselling

Interventions

Typology-based coaching BEHAVIORAL

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

Typology-based coaching

Eligibility Criteria

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

You may qualify if:

• Participant provides written informed consent prior to the beginning of trial-specific procedures.
• Patients must be aged ≥18 years on the day of signing informed consent.
• Participant has histologically confirmed primary invasive adenocarcinoma of the breast.
• Participant has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or progesterone receptor-positive breast cancer based on the most recently analyzed tissue sample tested by a local laboratory.
• Participant has HER2neg breast cancer defined as a negative ISH test or an IHC status of 0, 1+, or 2+. If the IHC is 2+, a negative ISH (e.g., FISH, CISH, SISH, or DISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
• Indication for treatment with ribociclib in combination with an aromatase inhibitor for early breast cancer according to the valid SmPC.
• Participant has adequate organ function amenable for treatment with ribociclib as assessed by a local laboratory.
• Female participants of childbearing potential must have had a hysterectomy or be willing to use highly effective methods of contraception and have a confirmed negative pregnancy test as assessed by local in-house standard.
• Participant is willing and able to comply with scheduled visits, treatment plans, and other trial procedures.

You may not qualify if:

• Patients with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
• Patients with serious preexisting medical condition(s) that would preclude participation in this study.
• Women who are pregnant or lactating.
• Patients with active bacterial infections (requiring IV antibiotics at time of initiating study treatment), fungal infections, or detectable viral infections (e.g., known human immunodeficiency virus positivity or known active hepatitis B or C, such as hepatitis B surface antigen-positive\]).
• 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 ribociclib according to the current SmPC.
• Patients with hypersensitivity to active substance of ribociclib, peanuts, soya or one of the other ingredients
• Patients who are not eligible for the trial due to severe comorbidities other than those mentioned above or unavailability according to the treating physician.

Sponsors & Collaborators

• Institut fuer Frauengesundheit: lead

Study Sites (3)

Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

RECRUITING

Department of Obstetrics and Gynecology, Uniklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie

Hösbach, Bavaria, 63768, Germany

RECRUITING

Study Officials

• Manfred Welslau, Dr. med.

  MVZ Klinikum Aschaffenburg, Zweigstelle Hänatologie und Onkologie

  PRINCIPAL INVESTIGATOR

• Nina Ditsch, Prof. Dr. med.

  Department of Gynecology and Obstetrics, Universitätsklinikum Augsburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Institut für Frauengesundheit GmbH

CONTACT

+49 9131 91880613; typer@ifg-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: November 4, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

DE (3)