Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007233

Trial Description

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Title

Clinical Cohort of Individual Expectations, Side Effects, Quality of Life and Adherence in Postoperative Women With Estrogen Receptor Positive Breast Cancer During Endocrine Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to evaluate the role of patients' response expectations for
nocebo side effects, quality of life and adherence during adjuvant endocrine treatment
(AET). Furthermore, this study analyses the effects of a structured treatment information on
patients' satisfaction with information, response expectations, knowledge and adherence.

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Brief Summary in Scientific Language

The majority of breast cancer patients discontinues today's standard adjuvant treatment
(endocrine therapy) due to side effects and reduced quality of life. Thereby, most side
effects are unspecific, suggesting a role of psychological factors as patients´ expectations
(nocebo effects). Moreover, patients are not informed sufficiently about their treatment.

Using a longitudinal design, the nature and onset of adverse side effects and their
association to treatment related expectations are investigated. Postoperative patients with
hormone receptor-positive breast cancer are assessed before the start of adjuvant treatment.
All patients receive standardized, additional information about endocrine therapy.
Expectations about side effects, knowledge and satisfaction with the enhanced information
are assessed before and after informing patients. Side effects, quality of life and
adherence are measured three months, two and five years after start of medication intake.

It will be analyzed if patients' response expectations predict side effects and quality of
life during medication intake to provide insights into pathways of clinical nocebo effects.
Further, this study examines the effects of a structured treatment information on patients'
satisfaction with information, response expectations, knowledge and adherence. The study
findings promise significant advances in the clinical nocebo research with strong
implications for clinical and research practice.

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Organizational Data

  •   DRKS00007233
  •   2016/01/29
  •   2014/03/12
  •   yes
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Secondary IDs

  •   NCT02088710  (ClinicalTrials.gov)
  •   BB-2011  (Philipps University Marburg Medical Center)
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Health Condition or Problem studied

  •   Female Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Behavioral: Enhanced information about endocrine therapy
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Adverse Side Effects; time frame: up to 5 years; General Assessment of Side Effects (GASE)

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Secondary Outcome

- Quality of Life; time frame: up to 5 years; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
- Adherence; time frame: up to 5 years; Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
- Knowledge; time frame: up to 5 years; Patients' knowledge of hormone receptor status of their tumor
- Satisfaction with Information; time frame: Baseline; Satisfaction with Information about Medicines Scale, (SIMS-D)
- Expectations; time frame: Baseline; General Assessment of Side Effects Scale - Expectations Module
- Coping with Side Effects; time frame: Follow-up (3 months, 2 years, 5 years); General Assessment of Side Effects Scale -Coping Module

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/01/31
  •   138
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Inclusion Criteria

  •   Female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Post surgery women with estrogen receptor positive breast cancer scheduled to start
first-line adjuvant endocrine therapy with Tamoxifen (+/- GnRH) or a third generation
Aromatase inhibitor at the Breast Cancer Centre

- Sufficient knowledge of German language and ability to give informed consent

- Age of 18 and more

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Exclusion Criteria

- Presence of a serious comorbid psychiatric condition (schizophrenia or addiction,
severe depression or anxiety)

- Presence of a life threatening comorbid medical condition

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Philipps University Marburg Medical Center
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    • Philipps University Marburg Medical Center
    • Yvonne Nestoriuc, PhD 
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    • Philipps University Marburg Medical Center
    • Yvonne Nestoriuc, PhD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.