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

Philipps University

Status: Unknown

Conditions: Female Breast Cancer

Treatments: Behavioral: Attention Control group (ACG); Behavioral: Side effect prevention training (SEPT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01741883

DFG NE 1635/2-1

Details and patient eligibility

About

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.

Full description

The majority of breast cancer patients discontinue today's standard adjuvant treatment (endocrine therapy) due to side effects and reduced quality of life. Thereby, most side effects are unspecific, thus, not related to the specific pharmacological action of the drug, but to the individual treatment context and patients´ expectations (nocebo effects). The aim of this study is to evaluate a side effect prevention training (SEPT) that optimizes patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during longer term drug intake. Using a randomized trial, we will study the time course of response expectations and side effects in breast cancer patients receiving either SEPT, standard medical care or an attention-control intervention ("supportive therapy") before the start of adjuvant endocrine therapy. We will analyze the effects of changing pre-treatment expectations on cancer-treatment related side effects, quality of life and adherence 3 and 6 months after the start of endocrine therapy. Moderator analyses will be used to determine predictors of non-specific medication side effects and patients that are at high risk of experiencing them. Furthermore, we will explore the mediating influence of coping behaviours, thereby providing insights into pathways of clinical nocebo effects. The study findings promise significant advances in the clinical application of nocebo research with strong implications for clinical and research practice.

Enrollment: 165 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

165 participants in 3 patient groups

Standard Medical Care and Information

No Intervention group

Description:

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 group

Description:

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

Treatment:

Behavioral: Side effect prevention training (SEPT)

Attention Control group (ACG)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Attention Control group (ACG)