Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
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| ClinicalTrials.gov Identifier: NCT02088710 |
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Recruitment Status : Unknown
Verified September 2017 by Yvonne Nestoriuc, PhD., Philipps University Marburg Medical Center.
Recruitment status was: Active, not recruiting
First Posted : March 17, 2014
Last Update Posted : September 26, 2017
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| Condition or disease | Intervention/treatment |
|---|---|
| Female Breast Cancer | Behavioral: Enhanced information about endocrine therapy |
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.
| Study Type : | Observational |
| Actual Enrollment : | 138 participants |
| 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 |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | December 2012 |
| Estimated Study Completion Date : | February 2020 |
- Behavioral: Enhanced information about endocrine therapy
Enhanced information about endocrine therapy, extending clinical routine information
- Adverse Side Effects [ Time Frame: up to 5 years ]General Assessment of Side Effects (GASE)
- 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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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088710
| Germany | |
| Philipps University Marburg Medical Center | |
| Marburg, Hessen, Germany, 35032 | |
| Principal Investigator: | Yvonne Nestoriuc, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | |
| Study Chair: | Winfried Rief, Prof. Dr. | Philipps University Marburg Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yvonne Nestoriuc, PhD., Prof. Dr., Philipps University Marburg Medical Center |
| ClinicalTrials.gov Identifier: | NCT02088710 |
| Other Study ID Numbers: |
BB-2011 |
| First Posted: | March 17, 2014 Key Record Dates |
| Last Update Posted: | September 26, 2017 |
| Last Verified: | September 2017 |
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Patients´ Expectations Breast Cancer Adjuvant Endocrine Treatment |
Nocebo Psycho-oncology Satisfaction with information |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |