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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02088710
Other study ID # BB-2011
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 12, 2014
Last updated September 24, 2017
Start date January 2011
Est. completion date February 2020

Study information

Verified date September 2017
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 138
Est. completion date February 2020
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced information about endocrine therapy
Enhanced information about endocrine therapy, extending clinical routine information

Locations

Country Name City State
Germany Philipps University Marburg Medical Center Marburg Hessen

Sponsors (1)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

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