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Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yvonne Nestoriuc, PhD., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:
NCT02088710
First received: March 12, 2014
Last updated: March 13, 2014
Last verified: March 2014

March 12, 2014
March 13, 2014
January 2011
January 2013   (final data collection date for primary outcome measure)
Adverse Side Effects [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
General Assessment of Side Effects (GASE)
Same as current
Complete list of historical versions of study NCT02088710 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
  • Knowledge [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Patients' knowledge of hormone receptor status of their tumor
  • Satisfaction with Information [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Satisfaction with Information about Medicines Scale, (SIMS-D)
  • Expectations [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    General Assessment of Side Effects Scale - Expectations Module
  • Coping with Side Effects [ Time Frame: Follow-up (3 months, 2 years, 5 years) ] [ Designated as safety issue: No ]
    General Assessment of Side Effects Scale -Coping Module
Same as current
Not Provided
Not Provided
 
Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
Clinical Cohort of Individual Expectations, Side Effects, Quality of Life and Adherence in Postoperative Women With Estrogen Receptor Positive Breast Cancer During Endocrine Therapy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

Female Breast Cancer
Behavioral: Enhanced information about endocrine therapy
Enhanced information about endocrine therapy, extending clinical routine information
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
January 2018
January 2013   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
  • Presence of a life threatening comorbid medical condition
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT02088710
BB-2011
No
Yvonne Nestoriuc, PhD., Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
Not Provided
Principal Investigator: Yvonne Nestoriuc, PhD Philipps University Marburg Medical Center
Study Chair: Winfried Rief, PhD Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP