Trial document




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  DRKS00024015

Trial Description

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Title

PRO B - patient-reported outcomes in breast diseases - New approaches in the care of metastatic breast cancer

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Trial Acronym

PRO B

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URL of the Trial

http://www.pro-b-projekt.de

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Brief Summary in Lay Language

PRO B stands for patient-reported outcomes in breast diseases. Patient-reported outcomes (PRO) are health-related aspects such as the health status or quality of life directly reported by the patients and without the intermediate interpretation of their treating physician. These aspects are measured with questionnaires.

The treatment of breast cancer patients is becoming increasingly individualized as a result of constant scientific advances. Against this backdrop, especially the care of patients with metastatic breast cancer poses a challenge for their doctors. Together with the patient they always have to base their decisions in this context on the patient's medical history and, in particular, the current complaints. In metastatic disease, the focus of care is on maintaining the best possible quality of life and controlling therapy side effects. Regular questioning of the patients affected about their health status, their quality of life and possible symptoms is therefore very helpful when choosing or adapting the treatment. Studies with metastatic cancer patients have shown that an intensified monitoring using regular PRO-surveys can lead to an improvement in quality of life and survival as well as a reduction in hospitalization and emergency room visits. The PRO B project is investigating whether this is also possible for the routine care of metastatic breast cancer patients in Germany, and whether this can improve their treatment.

The participating patients are asked about their general condition and quality of life either weekly or every three months with the help of a smartphone app. The group allocation is done randomly. In the group of patients surveyed weekly, an alarm is triggered and forwarded to the treating breast cancer center in case of worsening of symptoms or quality of life. The center then contacts the patient in order to specify the alarm. In this context, PRO B does not prescribe any measures that may be initiated. No alarm is triggered in the group of patients surveyed quarterly. For these patients, a report on the interviews is written at the end of the study, which can serve as a basis for discussion with the treating physicians.

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Brief Summary in Scientific Language

Breast cancer is the most common malignant disease of women worldwide. With the occurrence of metastases, not only the patients’ life circumstances but also therapeutical approaches change substantially as metastatic breast cancer is not yet curable. Instead, prolonging the survival and maintaining the best possible quality of life by controlling cancer progression and minimizing side effects become the leading treatment goals. However, taking into account the medical history, current complaints and the patient's wish, the decision process in this situation is often time consuming and has to be constantly reevaluated against the backdrop of disease progression.

In this case, information gathered by so-called patient-reported outcomes (PROs) is helpful to find the best possible treatment options. PROs facilitate the assessment of health-related aspects such as symptoms, psychosocial burden and quality of life from the patients' point of view and without intermediate interpretation by their doctors. Especially in metastatic disease, where patients should spend as little time as possible in the hospital and therapies are usually performed on an outpatient basis, regular PRO measurements allow a real-time monitoring of the health status and quality of life, thereby enabling timely adjustments of therapy if necessary. Recent research suggests that even a small deterioration in the quality of life of patients with metastatic breast cancer is associated with disease progression. Early detection of this deterioration via PRO monitoring could spare patients further cycles of a no longer effective therapy. In this context, studies have shown that an intensified PRO-monitoring of metastatic cancer patients can lead to an improvement in quality of life and survival as well as a reduction of unplanned hospitalization and emergency room visits.

PRO B expands a long-established, nationwide and standardized collection of quality assurance data by the German Cancer Society and the certification institute OnkoZert, thus improving the assessment of the course of metastatic breast cancer and its impact on the quality of life.


PRO B is a prospective, multicenter, randomized controlled, two-arm interventional trial implementing and evaluating an intensified digital patient-reported outcome (PRO) monitoring. With the help of an app, the participating patients are asked about their general condition and quality of life either weekly or every three months. The group allocation is done by randomization. In the group of patients surveyed weekly, an alarm is triggered and forwarded to the treating breast cancer center in case of worsening of symptoms or quality of life. The center then contacts the patient in order to specify the alarm. In this context, PRO B does not prescribe any measures that may be initiated. No alarm is triggered in the group of patients surveyed quarterly. For these patients, a report on the interviews is written at the end of the study, which can serve as a basis for discussion with the treating physicians.

The aim of the study is to reduce disease-related morbidity and improve the quality of life of patients with metastatic breast cancer.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

For data protection reasons, no individual study data of the participants will be passed on to third parties.

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Organizational Data

  •   DRKS00024015
  •   2021/02/15
  •   [---]*
  •   yes
  •   Approved
  •   EA1/318/20, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1263-4946 
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Patients receive a weekly PRO survey via smartphone app which triggers an alarm to the treating breast cancer center in case of worsening values. They will be contacted by their treating physician to specify the alarm.
  •   Patients receive a quarterly PRO survey via smartphone app. In the control group, the app does not generate an alarm in case of worsening of the PRO-values.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint of the study is fatigue at 6 months, measured with a study-specific questionnaire consisting of items from the EORTC CAT item bank via a smartphone app

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Secondary Outcome

Secondary endpoints are overall survival, unplanned medical consultations, hospitalizations and emergency room visits.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/05/17
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Women
- with metastatic breast cancer,
- who are treated in a participating breast cancer center,
- who are insured with one of the following health insurance companies: BARMER, DAK Gesundheit, BKK-VBU*,
- who are able to consent,
- who are older than 18,
- who are receiving drug treatment for metastatic breast cancer,
- who have a life expectancy of more than 3 months at enrollment,
- who are classified as ECOG 0-2,
- who are willing to participate in a weekly, online-based PRO survey,
- and who have access to the internet (smartphone, tablet)
may be included.

*after extension of the legal basis, participation is temporarily possible for patients of other health insurance companies

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Exclusion Criteria

Patients who do not receive active cancer therapy (comfort care) or who do not meet all of the inclusion criteria are not eligible to participate.

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Addresses

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    • Charité - Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Klinik für Gynäkologie mit Brustzentrum, Charité - Universitätsmedizin Berlin
    • Ms.  Dr. med.  Maria Margarete  Karsten 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • PRO B Studienzentrale, Klinik für Gynäkologie mit Brustzentrum, Charité Universitätsmedizin Berlin
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Postfach 12 06 06
    • 10596  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.