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Female Breast CancerNCT01741883

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

A study testing Side effect prevention training (SEPT) in people with Female Breast Cancer, run by Philipps University Marburg at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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?
Side effect prevention training (SEPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteGermany
Study dates
Nov 2012to Aug 2020
Phase
Interventional
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

Who may be able to join

  • 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

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20251

Other trials in Germany

About this study

Official title: Clinical Application of Nocebo Research: Optimizing Expectations of Breast Cancer Patients to Prevent Nocebo Side Effects and Decrease of Quality of Life During Adjuvant Endocrine Therapy (DFG, NE 1635/2-1)

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.

Read the detailed 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.

Being tested
Side effect prevention training (SEPT), Attention Control group (ACG)
Keywords
Randomized Controlled Trial, Patients´ Expectations, Breast Cancer, Adjuvant Endocrine Treatment, Nocebo
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Side effect prevention training (SEPT)Behavioural

    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.

  • Attention Control group (ACG)Behavioural

    Also called Supportive therapy

    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).

Study groups in NCT01741883
Study groupRoleWhat they receive
Standard Medical Care and InformationNo interventionPatients receive standard treatment protocol for breast cancer patients and additional oral and written information about adjuvant endocrine treatment.
Side effect prevention training (SEPT)ExperimentalPatients receive standard medical care and a brief behavioral intervention that targets patients' response and coping expectations while starting with adjuvant endocrine treatment.
Receives: Behavioral: Side effect prevention training (SEPT)
Attention Control group (ACG)Active comparatorPatients receive standard medical care and a comparable amount of therapist´s attention (common and unspecific factors) to the intervention group without targeting patients´ expectations.
Receives: Behavioral: Attention Control group (ACG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

  1. 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)

    Change in patients expectations from baseline/pre-intervention (expected average 2 weeks after surgery) to post-intervention (expected average 5 weeks after surgery) and prospective expectations 3 and 6 months after the start of adjuvant endocrine therapy

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

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

    Change in anxiety and depression from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET

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

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

    Change in Fear of Progression from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET

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

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

    Change in Adherence Intention and Adherence from baseline to 5 weeks after surgery to 3 months after the start of AET to 6 months after the start of AET

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

  5. 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)

    Change in Quality of Life from baseline to 3 months after the start of adjuvant endocrine therapy to 6 months after the start of adjuvant endocrine therapy

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

  6. Change in Coping with Side Effects (General Assessment of Side Effects-Cope, GASE-Cope)

    Change in coping with Side Effects from 3 months after the start of adjuvant endocrine therapy to 6 months after the start of adjuvant endocrine therapy

    Measured: 3 and 6 months after the start of adjuvant endocrine therapy (AET)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2015
  4. Study completionAug 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741883
Sponsor's protocol ID
DFG NE 1635/2-1
Status last verified
Sep 2017
First submitted
4 Dec 2012
Last updated
26 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24047450

  • 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.

    PubMed 26913587

Questions about this trial

What is this clinical trial studying?

A study testing Side effect prevention training (SEPT) in people with 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?

Side Effects (General Assessment of Side Effects, GASE) (time frame: Baseline, 3 and 6 months after the start of adjuvant endocrine therapy (AET)). 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 NCT01741883, 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.

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