Clinical trial NCT05019612: The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women
Official title: The Role of Expectations on Complaints and Well-being After Endometriosis Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Expectations
Laparoscopy
Keywords: cohort study
endometriosis
surgery
laparoscopy
expectation
nocebo
placebo
Lead sponsor: Helmut Schmidt University
Sponsor class: OTHER
Collaborators: name: Frauenklinik an der Elbe
First posted: 2021-08-25
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be selected who are treated in the Frauenklinik an der Elbe.

Brief summary: Endometriosis is a prevalent disease in women of procreative age. Most endometriosis patients are affected in their daily life by complaints such as chronic pelvic pain, dysmenorrhoea, infertility, or pain during sexual intercourse. Yet, its etiology is poorly understood. Although laparoscopy is well known as the gold standard for treating endometriosis, 20-30% of treated women still show persistent complaints following successful laparoscopy.

It has been widely recognized that expectations profoundly affect treatment courses and outcomes in many different health conditions. Additionally, evidence suggests that optimizing preoperative expectations can improve post-operative outcomes such as disability and return to work.

The objective of this study is to investigate whether expectations also affect treatment course and outcome in women after endometriosis surgery. For this purpose, the investigators conduct a mixed-method observational cohort study to gather data on psychological factors, particularly treatment and symptom-related expectations, as well as complaints and well-being of patients after surgery. A sample of N = 300 women will be asked pre- and postoperatively to evaluate these psychological factors and indicators of treatment course and outcome. Overall, the study will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery.

The study aims to determine potential interactions between aforementioned psychological factors, their influence on the postoperative health, and the long- and short-term symptom course of patients with endometriosis. The study results will provide a better understanding of the symptom- and treatment course in women with endometriosis and subsequently supply clinical approaches to optimize treatment of endometriosis.

Detailed description: Rationale:

According to the evidence-based S2-treatment guidelines for endometriosis, laparoscopy is the method of choice to remove endometriosis and is associated with considerable symptom improvement. However, 20-30% of treated women (so-called non-responders) still report symptoms and impairments after surgery; this is not explainable by laparoscopy itself or a recurrence of endometriosis. Relevant psychosocial predictors are higher age and pain catastrophization, though both only explain a small amount of persistent symptoms and impairments. This indicates a potential role of other psychological factors influencing treatment outcome, such as expectations.

Evidence for this assumption is provided by placebo-response rates of 30% in women who had a sham endometriosis surgery and even reported symptom improvements after diagnostic (sham) laparoscopy. Concerning other gynaecological settings, research already implies that expectations have a remarkable impact on treatment outcome and quality of life in women with breast cancer. Likewise, the role of expectations could be important for the optimal treatment of endometriosis.

However, there is no study examining the role of expectations on treatment outcomes in women with endometriosis to date. Therefore, this study investigates the influence of expectations and other psychological factors on complaints and well-being of patients after surgery in women with endometriosis.

Method:

In the proposed study, a sample of 300 women will report pre- and postoperatively about their treatment and symptom expectations, health condition, and other psychological factors that may influence treatment course and outcome after endometriosis surgery. Overall, this monitoring will last 12 months, including one assessment preoperatively (baseline), seven monthly assessments postoperatively, and a follow-up assessment 12 months after endometriosis surgery. All assessments will be conducted online.

Within the scope of an embedded qualitative study, a partial sample of 20 to 30 women will be interviewed preoperatively and postoperatively about their treatment and symptom expectations, fears, and concerns regarding the laparoscopy.

Above that, a second partial sample of 20 women will report on seven consecutive days about their current health condition, and treatment and symptom expectations in their everyday life using ambulatory assessment (smartphone-based measurements).

Objectives:

Firstly, the investigators are interested in the treatment course and outcome and its possible changes over a period of six months after endometriosis surgery. Secondly, the role of pre- and post-operative expectations for treatment course and outcome for women with endometriosis should be determined. Besides expectations, the investigators will finally examine further potential psychological and social predictors for treatment outcome, e.g., prior treatment experiences, state anxiety, depression, pain catastrophization and demographics, in order to optimize endometriosis therapy.

Regarding the embedded qualitative study, the investigators explore and categorize the mentioned treatment- and symptom-related expectations concerning endometriosis surgery (laparoscopy) and psychological factors that potentially improve or harm women's treatment outcome and health condition. The ambulatory assessment offers a monitoring of patients' symptom course in their daily lives and the determination of potential modulators

Eligibility criteria: Inclusion Criteria:

1. Adult women (18+)
2. Endometriosis related symptoms and complaints
3. Clinical indication for surgery/laparoscopy
4. Clinically diagnosed endometriosis (postoperatively)
5. Informed consent
6. Sufficient knowledge of the German language

Exclusion Criteria:

1. Incomplete excision of endometriosis
2. Malignant biopsy result (postoperatively)

Primary outcomes:
measure: Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow-up 12 months after surgery
Secondary outcomes:
measure: Severity of endometriosis-related complaints - self-conducted rating scale (NRScomplaints)
timeFrame: at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery
measure: Mental well-being - Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery
measure: Health related quality of life - Endometriosis Health Profile (EHP-5)
timeFrame: at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery
measure: Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)
timeFrame: Continuous measurement postoperatively, seven times with an interval of four weeks
Other outcomes:
measure: Impairments by somatic symptoms - Patient Health Questionnaire (PHQ-15)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery
measure: Treatment expectations - Treatment Expectation Questionnaire (TEX-Q)
timeFrame: at baseline
measure: Expected Endometriosis Pain Disability - Pain Disability Index, adapted (PDI-expect)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery
measure: Symptom expectation - self-conducted rating scale (NRS_Symptomexpect)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery
measure: Pre-experiences with endometriosis treatment/surgery - Generic rating scale for previous treatment experiences (GEEE_PRE)
timeFrame: at baseline
measure: Treatment expectations - Generic rating scale for treatment expectations (GEEEEXP)
timeFrame: at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery
measure: Depressive and anxiety - Patient Health Questionnaire (PHQ-4)
timeFrame: at baseline
measure: Pain Catastrophization - subscale of the Coping- strategy questionnaire (CSQ-D)
timeFrame: at baseline
Locations:
city: Hamburg
country: Germany
facility: Helmut Schmidt University
Study officials:
affiliation: Helmut Schmidt University/ University of the Federal Armed Forces Hamburg
name: Yvonne Nestoriuc, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Heisig SR, Shedden-Mora MC, von Blanckenburg P, Schuricht F, Rief W, Albert US, Nestoriuc Y. Informing women with breast cancer about endocrine therapy: effects on knowledge and adherence. Psychooncology. 2015 Feb;24(2):130-7. doi: 10.1002/pon.3611. Epub 2014 Jun 21.
citation: 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.
citation: Pan Y, Kinitz T, Stapic M, Nestoriuc Y. Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. Front Psychiatry. 2019 Jul 25;10:504. doi: 10.3389/fpsyt.2019.00504. eCollection 2019.
citation: Quidde J, Pan Y, Salm M, Hendi A, Nilsson S, Oechsle K, Stein A, Nestoriuc Y. Preventing adverse events of chemotherapy by educating patients about the nocebo effect (RENNO study) - study protocol of a randomized controlled trial with gastrointestinal cancer patients. BMC Cancer. 2018 Sep 24;18(1):916. doi: 10.1186/s12885-018-4814-7.
citation: Shedden-Mora MC, Pan Y, Heisig SR, von Blanckenburg P, Rief W, Witzel I, Albert US, Nestoriuc Y. Optimizing Expectations About Endocrine Treatment for Breast Cancer: Results of the Randomized Controlled PSY-BREAST Trial. Clin Psychol Eur. 2020 Mar 31;2(1):e2695. doi: 10.32872/cpe.v2i1.2695. eCollection 2020 Mar.
citation: Nestoriuc Y, Kleine-Borgmann J. [Appearances are not deceptive: clinical evidence and new research approaches to open-label placebo]. Nervenarzt. 2020 Aug;91(8):708-713. doi: 10.1007/s00115-020-00953-6. German.