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
  Purpose

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.


Condition Intervention
Female Breast Cancer
Behavioral: Enhanced information about endocrine therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Adverse Side Effects [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    General Assessment of Side Effects (GASE)


Secondary Outcome Measures:
  • 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


Enrollment: 138
Study Start Date: January 2011
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Enhanced information about endocrine therapy
    Enhanced information about endocrine therapy, extending clinical routine information
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02088710

Locations
Germany
Philipps University Marburg Medical Center
Marburg, Hessen, Germany, 35032
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
Principal Investigator: Yvonne Nestoriuc, PhD Philipps University Marburg Medical Center
Study Chair: Winfried Rief, PhD Philipps University Marburg Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Yvonne Nestoriuc, PhD., Prof. Dr., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT02088710     History of Changes
Other Study ID Numbers: BB-2011
Study First Received: March 12, 2014
Last Updated: March 13, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Philipps University Marburg Medical Center:
Patients´ Expectations
Breast Cancer
Adjuvant Endocrine Treatment
Nocebo
Psycho-oncology
Satisfaction with information

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014