Female Breast CancerNCT02088710
Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
An observational study of Female Breast Cancer, run by Philipps University Marburg at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- Enhanced information about endocrine therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
- Presence of a life threatening comorbid medical condition
Trial locations and contacts
1 site in 1 country.
Germany1 site
Philipps University Marburg Medical Center
Marburg, Hesse, 35032
About this study
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
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.
Read the 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.
- Conditions
- Female Breast Cancer
- Being tested
- Enhanced information about endocrine therapy
- Keywords
- Patients´ Expectations, Breast Cancer, Adjuvant Endocrine Treatment, Nocebo, Psycho-oncology, Satisfaction with information
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced information about endocrine therapyBehavioural
Enhanced information about endocrine therapy, extending clinical routine information
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Side Effects
General Assessment of Side Effects (GASE)
Measured: up to 5 years
Secondary outcomes (6)
Quality of Life
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
Measured: up to 5 years
Adherence
Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
Measured: up to 5 years
Knowledge
Patients' knowledge of hormone receptor status of their tumor
Measured: up to 5 years
Satisfaction with Information
Satisfaction with Information about Medicines Scale, (SIMS-D)
Measured: Baseline
Expectations
General Assessment of Side Effects Scale - Expectations Module
Measured: Baseline
Coping with Side Effects
General Assessment of Side Effects Scale -Coping Module
Measured: Follow-up (3 months, 2 years, 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Nestoriuc, PhD., Philipps University Marburg
- Investigators
- Yvonne Nestoriuc, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-EppendorfWinfried Rief, Prof. Dr., Study chair, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088710
- Sponsor's protocol ID
- BB-2011
- Status last verified
- Sep 2017
- First submitted
- 12 Mar 2014
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pan Y, Heisig SR, von Blanckenburg P, Albert US, Hadji P, Rief W, Nestoriuc Y. Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study. Breast Cancer Res Treat. 2018 Apr;168(3):667-677. doi: 10.1007/s10549-017-4637-2. Epub 2018 Jan 12.
PubMed 29330625Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P, Albert US, Rief W. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol. 2016 Oct;27(10):1909-15. doi: 10.1093/annonc/mdw266. Epub 2016 Aug 22.
PubMed 27551051
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02088710
- Acronym / sponsor ID
- BB-2011
- Conditions
- Female Breast Cancer
- Keywords
- Patients´ Expectations, Breast Cancer, Adjuvant Endocrine Treatment, Nocebo, Psycho-oncology, Satisfaction with information
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
- Presence of a life threatening comorbid medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced information about endocrine therapyEnhanced information about endocrine therapy, extending clinical routine information | Behavioural | – |
Primary outcome
Adverse Side Effects
Time frame: up to 5 years
General Assessment of Side Effects (GASE)
6 secondary outcomes
Quality of Life
Time frame: up to 5 years
Adherence
Time frame: up to 5 years
Knowledge
Time frame: up to 5 years
Satisfaction with Information
Time frame: Baseline
Expectations
Time frame: Baseline
Coping with Side Effects
Time frame: Follow-up (3 months, 2 years, 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Derived from this study: PubMed 29330625Pan Y, Heisig SR, von Blanckenburg P, Albert US, Hadji P, Rief W, Nestoriuc Y. Facilitating adherence to endocrine therapy in breast cancer: stability and predictive power of treatment expectations in a 2-year prospective study. Breast Cancer Res Treat. 2018 Apr;168(3):667-677. doi: 10.1007/s10549-017-4637-2. Epub 2018 Jan 12.
- Derived from this study: PubMed 27551051Nestoriuc Y, von Blanckenburg P, Schuricht F, Barsky AJ, Hadji P, Albert US, Rief W. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study. Ann Oncol. 2016 Oct;27(10):1909-15. doi: 10.1093/annonc/mdw266. Epub 2016 Aug 22.
- Homepage of the research unit (FOR 1328): Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applicationsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Nestoriuc, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Winfried Rief, Prof. Dr. study chair
Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Breast Cancer, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Side Effects (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088710, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.