The Role of Expectations on Complaints and Well-being After Endometriosis Surgery in Women

NCT05019612 | Unknown

• 1 other identifier: ROXWELL-2021-HH
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Expectations; Laparoscopy

Keywords

cohort study; endometriosis; surgery; laparoscopy; expectation; nocebo; placebo

Outcome Measures

Primary Outcomes (1)

• Course of Endometriosis related Pain Disability - Pain Disability Index (PDI-D)

  The PDI-D assesses the self-reported disability by endometriosis symptoms using a numeric rating scale with eleven response options (0-10). The overall total score will be calculated by gathering all seven items. The course of endometriosis related pain disability over the measurement points will be analysed as the primary outcome.

  at baseline, seven times consecutive with an interval of four weeks, follow-up 12 months after surgery

Secondary Outcomes (4)

• Severity of endometriosis-related complaints - self-conducted rating scale (NRScomplaints)

  at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery

• Mental well-being - Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)

  at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery

• Health related quality of life - Endometriosis Health Profile (EHP-5)

  at baseline, seven times consecutive with an interval of 4 weeks, follow up 12 months after surgery

• Current Treatment effects - 'Generic rating scale for treatment effects' (GEEE_ACT)

  Continuous measurement postoperatively, seven times with an interval of four weeks

Other Outcomes (8)

• Impairments by somatic symptoms - Patient Health Questionnaire (PHQ-15)

  at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery

• Treatment expectations - Treatment Expectation Questionnaire (TEX-Q)

  at baseline

• Expected Endometriosis Pain Disability - Pain Disability Index, adapted (PDI-expect)

  at baseline, seven times consecutive with an interval of four weeks, follow up 12 months after surgery

Study Arms (1)

single-group/one cohort

Women with endometriosis, having the clinical indication for laparoscopic endometriosis excision

Procedure: Laparoscopy: A minimal invasive surgery

Interventions

Laparoscopy: A minimal invasive surgery PROCEDURE

A low-risk minimal invasive surgery performed in the pelvis using small incisions. With the aid of a laparoscope, the operator views the affected area in real-time. Beyond that, the camera sends images to a video monitor. The operator obtains endometriosis and biopsy samples with small surgical instruments. Before laparoscopy, individuals are provided with a general anaesthetic to relax muscles and prevent pain during surgery.

single-group/one cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Endometriosis is a chronic disease affecting individuals of the female biological sex
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women will be selected who are treated in the Frauenklinik an der Elbe.

You may qualify if:

• Adult women (18+)
• Endometriosis related symptoms and complaints
• Clinical indication for surgery/laparoscopy
• Clinically diagnosed endometriosis (postoperatively)
• Informed consent
• Sufficient knowledge of the German language

You may not qualify if:

• Incomplete excision of endometriosis
• Malignant biopsy result (postoperatively)

Sponsors & Collaborators

• Helmut Schmidt University: lead
• Frauenklinik an der Elbe: collaborator

Study Sites (1)

Helmut Schmidt University

Hamburg, Germany

Location

Related Publications (9)

• 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, 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.

  PMID: 24953538 BACKGROUND

• 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.

  PMID: 27551051 BACKGROUND

• 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.

  PMID: 31427995 BACKGROUND

• 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.

  PMID: 30249191 BACKGROUND

• 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.

  PMID: 36397978 BACKGROUND

• 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.

  PMID: 32691079 BACKGROUND

• Meyrose AK, Basedow LA, Hirsing N, Buchweitz O, Rief W, Nestoriuc Y. Assessment of treatment expectations in people with suspected endometriosis: A psychometric analysis. F1000Res. 2024 Sep 9;13:174. doi: 10.12688/f1000research.145377.2. eCollection 2024.

  PMID: 39328391 DERIVED

• Hirsing N, Meyrose AK, Buchweitz O, Nestoriuc Y. Do expectations determine postoperative disability in women with endometriosis? Study protocol for a clinical mixed-methods observational cohort study. BMJ Open. 2023 Jan 4;13(1):e067497. doi: 10.1136/bmjopen-2022-067497.

  PMID: 36599637 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yvonne Nestoriuc, Prof. Dr.

  Helmut Schmidt University/ University of the Federal Armed Forces Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 25, 2021
• Study Start: August 25, 2021
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available when the main research questions were answered by the investigators.
• Access Criteria: Anyone who whishes to access the quantitative data. Transcripts are available upon reasonable request.

Locations

DE (1)