- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02088710
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Hessen
-
Marburg, Hessen, Tyskland, 35032
- Philipps University Marburg Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Side Effects
Tidsramme: up to 5 years
|
General Assessment of Side Effects (GASE)
|
up to 5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life
Tidsramme: up to 5 years
|
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with breast module (QLQ-BR23)
|
up to 5 years
|
|
Adherence
Tidsramme: up to 5 years
|
Medication Adherence Report Scale (MARS-D); Adherence with endocrine treatment; reasons for non-adherence
|
up to 5 years
|
|
Knowledge
Tidsramme: up to 5 years
|
Patients' knowledge of hormone receptor status of their tumor
|
up to 5 years
|
|
Satisfaction with Information
Tidsramme: Baseline
|
Satisfaction with Information about Medicines Scale, (SIMS-D)
|
Baseline
|
|
Expectations
Tidsramme: Baseline
|
General Assessment of Side Effects Scale - Expectations Module
|
Baseline
|
|
Coping with Side Effects
Tidsramme: Follow-up (3 months, 2 years, 5 years)
|
General Assessment of Side Effects Scale -Coping Module
|
Follow-up (3 months, 2 years, 5 years)
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Winfried Rief, Prof. Dr., Philipps University Marburg Medical Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Nestoriuc 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BB-2011
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