Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients

NCT01741883 | Unknown

• 1 other identifier: DFG NE 1635/2-1
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of adjuvant endocrine treatment (AET) to prevent nocebo side effects and enhance quality of life during longer term drug intake.

Conditions

Female Breast Cancer

Keywords

Randomized Controlled Trial; Patients´ Expectations; Breast Cancer; Adjuvant Endocrine Treatment; Nocebo

Outcome Measures

Primary Outcomes (1)

• Side Effects (General Assessment of Side Effects, GASE)

  Side Effects 3 and 6 months after the start of adjuvant endocrine therapy, controlled for baseline symptoms, staging, age, medication

  Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)

Secondary Outcomes (6)

• Change in Patients Expectations (General Assessment of Side Effects-Expect/Cope, Gase-Expect/Cope; Brief Illness Perceptions Questionnaire, B-IPQ; Beliefs about medicine questionnaire, BMQ-D)

  Baseline and 5 weeks after surgery, before start of adjuvant endocrine therapy

• Change in Anxiety and Depression (Hospital Anxiety and Depression Scale, HADS-D)

  Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET

• Change in Fear of Progression (Fear of Progression Questionnaire-Short Form, FoP-Q-SF)

  Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET

• Change in Adherence Intention and Adherence (Medication Adherence Report Scale, MARS-D)

  Baseline, 5 weeks after surgery, 3 months after the start of adjuvant endocrine therapy (AET) and 6 months after the start of AET

• Change in Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire with breast module, EORTC QLQ-C30 and QLQ-BR23)

  Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)

Study Arms (3)

Standard Medical Care and Information

NO INTERVENTION

Patients receive standard treatment protocol for breast cancer patients and additional oral and written information about adjuvant endocrine treatment.

Side effect prevention training (SEPT)

EXPERIMENTAL

Patients receive standard medical care and a brief behavioral intervention that targets patients' response and coping expectations while starting with adjuvant endocrine treatment.

Behavioral: Side effect prevention training (SEPT)

Attention Control group (ACG)

ACTIVE COMPARATOR

Patients receive standard medical care and a comparable amount of therapist´s attention (common and unspecific factors) to the intervention group without targeting patients´ expectations.

Behavioral: Attention Control group (ACG)

Interventions

Side effect prevention training (SEPT) BEHAVIORAL

SEPT is aimed to optimize patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during adjuvant endocrine treatment. SEPT is a three session cognitive-behavioural training. It includes psychoeducation about AET to provide a realistic view on AET, reduction of concerns about side effects and strengthening of necessity beliefs. Further contents are side effect management training and problem solving to enhance self-efficacy expectations about coping as well as imagination training to integrate positive aspects of medication into daily life.

Side effect prevention training (SEPT)

Attention Control group (ACG) BEHAVIORAL

Supportive therapy includes common or unspecific factors such as elicitation of affect, a treatment context, empathy, reflective listening, and feeling understood. Supportive therapy thus provides a control condition for common factors and therapist attention, while lacking the specific intervention part. It will be delivered in the same frequency and at the same time points as the side effect prevention training (three individual sessions and three booster telephone calls).

Also known as: Supportive therapy

Attention Control group (ACG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of a serious comorbid psychiatric condition (schizophrenia or addiction, severe depression or anxiety)
• Presence of a life threatening comorbid medical condition

Sponsors & Collaborators

• Philipps University Marburg: lead
• University of Hamburg-Eppendorf: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Related Publications (2)

• von Blanckenburg P, Schuricht F, Albert US, Rief W, Nestoriuc Y. Optimizing expectations to prevent side effects and enhance quality of life in breast cancer patients undergoing endocrine therapy: study protocol of a randomized controlled trial. BMC Cancer. 2013 Sep 18;13:426. doi: 10.1186/1471-2407-13-426.

  PMID: 24047450 BACKGROUND

• Heisig SR, Shedden-Mora MC, von Blanckenburg P, Rief W, Witzel I, Albert US, Nestoriuc Y. What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy. Psychooncology. 2016 Dec;25(12):1485-1492. doi: 10.1002/pon.4089. Epub 2016 Feb 23.

  PMID: 26913587 DERIVED

Related Links

• Homepage of the transregional DFG research unit FOR 1328: Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applications

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yvonne Nestoriuc, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Winfried Rief, Prof. Dr.

  Philipps University Marburg, Department of Psychology, Division of Clinical Psychology and Psychotherapy

  PRINCIPAL INVESTIGATOR

• Ute-Susann Albert, Prof. Dr.

  Krankenhaus Nordwest, Department of Gynecology and Obstetrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 5, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2020
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

DE (1)