PaTypRecruiting

Study to Identify Individual Needs for Tailored Coaching During Anti-Hormone Therapy for Hormone-Receptor-Positive Breast Cancer

Gender
Women
Age
All ages
Trial type
Interventional
Line of therapy
First line
Phase

What is this trial about?

Breast cancer treatment can be extremely stressful for patients. In particular, treatment for hormone receptor-positive breast cancer is very lengthy (5–10 years) and is perceived as burdensome by many patients. The goal of the PaTyp study is to categorize patients into groups (types) that correspond to their individual needs and to develop tailored support services. This is intended to improve adherence to antihormonal therapy. Breast cancer patients who have completed the first phase of their treatment and are receiving adjuvant, multi-year anti-hormonal therapy that began no more than eight weeks ago are eligible to participate in the study.

Trial flow

Requirements

Diagnosis: Breast cancer

Line of therapy: Erstlinie / bisher keine Therapie

Key inclusion criteria: Hormone receptor-positive; after primary therapy; during anti-hormone therapy (max. 8 weeks after initiation)

Allocation

Randomisierung

Treatment

approx. 52 weeks
Classification into patient types and tailored coaching4 types; 30-minute questionnaire
Standard information about adjuvant anti-hormone therapy

Follow-up

24 months

Detailed description

A common characteristic of breast cancer cells is the presence of a hormone receptor on their surface. About 70 percent of all breast cancer patients have a hormone receptor-positive tumor. This means that female hormones, particularly estrogen, promote cancer growth by binding to the tumor cells. For this reason, medications are used that specifically block the release of these hormones. Follow-up treatment (adjuvant therapy) for the disease after chemotherapy and surgery therefore often consists of anti-hormone therapy, as this can help combat any remaining tumor cells. However, this therapy usually lasts several years, in some cases up to ten years. However, about half of all patients discontinue therapy within five years, with a significant proportion stopping as early as the first year. Reasons for discontinuing therapy include severe physical and psychological side effects that resemble symptoms experienced during menopause. This poses a major challenge for treatment. Social research studies show that patients are less likely to suffer from these symptoms and less likely to discontinue therapy if they are well-informed about the treatment and feel they can cope with the associated challenges on their own.

The PaTyp study therefore aims to document patients’ responses to anti-hormone therapy, particularly with regard to their acceptance of the disease and their sense of control over its progression. Based on these individual needs, patients will be divided into four different groups (types), for each of which specific support services will be developed. Such an approach is not yet standard practice. To evaluate the success of the intervention, patients will be randomly assigned to two groups. One group receives type-specific coaching, while the other group is treated according to current standard procedures (i.e., does not receive coaching). The patients are monitored over a total period of 24 months. New medications are not being evaluated in this study.

Breast cancer patients with hormone-receptor-positive breast cancer are eligible to participate in the study. The first phase of treatment (usually chemotherapy and surgery) must already be complete, and they must be receiving adjuvant anti-hormone therapy. This treatment must have begun no more than eight weeks ago. The cancer must not have spread (metastasized) throughout the body.

Facts

  1. Disease: Breast cancer (mammary carcinoma)
  2. Cancer characteristics: Hormone receptor-positive, first phase of treatment (neoadjuvant therapy and surgery) already completed, start of adjuvant anti-hormone therapy (no more than 8 weeks ago)
  3. What the study examines: The effectiveness of individualized coaching—based on classification into one of four types—on treatment adherence
  4. Study objective: To improve the quality of care and adherence to anti-hormone therapy among patients with breast cancer
  5. Study duration: Maximum 24-month observation period
  6. Study characteristics: Randomized, open-label, two-arm study, multicenter

Trial sites

26 trial sites in Germany are listed. Find a site near you.

  • Klinikum Ansbach Gynäkologische Onkologie

    Ansbach

    Status unknown
  • Studienzentrum

    Aschaffenburg

    Status unknown
  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Studienzentrum

    Berlin

    Status unknown
  • Studienzentrum

    Bonn

    Status unknown
  • Marienhospital Bottrop gGmbH

    Josef-Albers-Straße 70, 46236 Bottrop

    Status unknown

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.