Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients

October 31, 2022 updated by: Gizem Fariz, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Breast cancer is the most common type of cancer in women. Anxiety and depression often accompany the treatment phase of oncology patients.

Since both anxiety and depression are associated with increased inflammatory activity, these preoperative symptoms may predispose patients to the development of postoperative neurocognitive dysfunction.

The aim of this study is to reveal the correlation of preoperative anxiety with early postoperative cognitive dysfunction in patients with breast cancer who will undergo surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the treatment of oncological disease, %13-19 of these patients show symptoms of anxiety and depression.Although many factors affect the development of postoperative cognitive dysfunction, there are several well-known risk factors and are thought to be due to increased inflammatory activity. Inflammation and immune dysfunction are common in oncological patients. It has also been reported that the presence of increased central nervous system inflammatory reactivity affects cognitive function.Since both anxiety and depression are associated with increased inflammatory activity, these preoperative symptoms may predispose patients to the development of postoperative neurocognitive dysfunction.

Postoperative cognitive dysfunction is an unwanted postoperative condition and is thought to be particularly relevant to elderly patients. Most studies in the literature have focused on the elderly. However, younger patients tend to experience more anxiety and depression during cancer treatment.

Studies indicate that age is inversely correlated with emotional distress and younger patients tend to experience higher levels of anxiety during diagnosis and treatment.

Also, younger patients have more limited life experiences to help them cope with such traumatic situations. The preoperative anxiety rate was found twice as high in female patients compared to male patients. Younger patients with bone cancer, breast cancer, and prostate cancer were three times more likely to report anxiety among the tumor groups than older patients.

Although the definition, degree and duration of postoperative cognitive dysfunction have been well researched, the effect of preoperative anxiety on the development of postoperative cognitive dysfunction has not been studied in detail.

Patients who are scheduled for elective breast surgery will be included in the study, who are informed and agree to participate in the study.

From the beginning of the study, consecutive patients will be included in the study.Preoperative MoCA test and State-Trait Anxiety Inventory Test (STAI FORM) questionnaire form will be filled in with the patient through one-on-one interview and in the early postoperative period. After the test ASA scores, age, comorbidities, demographic data, education levels, duration of anesthesia and surgery, and vital parameters will be recorded.

(1st week) MoCA test will be applied and its relationship with POCD will be checked.

Patients with preoperative MoCA score (M0) 21/30 points and above; It will be re-evaluated on the 7th postoperative day (M1) and a 4 unit decrease in M1 score from M0 score will be considered as POCD.

The correlation between preoperative anxiety level and early postoperative cognitive dysfunction (POCD) will be investigated.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital clinic of Anesthesiology and Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Female patients aged 18-65 years who are scheduled for elective surgery due to breast malignancy who meet the inclusion criteria

Description

Inclusion Criteria:

  1. Should be female
  2. Should be between 18-65 years old
  3. Diagnosed with breast cancer
  4. Scoring 21 or above in the MoCA test,
  5. Patients under general anesthesia
  6. Are decided to have Total Mastectomy, Modified Radical Mastectomy or Breast Conserving surgery
  7. Having a risk score of The American society of Anesthesiologists (ASA) risk score 3 and below

Exclusion Criteria:

  1. Cerebral ischemia or hemorrhage history
  2. Clinical diagnosis of Neurodegenerative disease
  3. Clinical diagnosis of carotid stenosis,
  4. The score 20 or less in the Moca test,
  5. Carotid endarterectomy history
  6. Aneurysm surgery history
  7. Alcohol addiction
  8. Clinical diagnosis of psychiatric disease
  9. Cervical surgery history
  10. Inability to comply with the questionnaire or study
  11. Chemotherapy history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the preoperative anxiety level and evaluating the difference between the preoperative moca test and the moca test performed on the postoperative 7th day (early period)
Time Frame: 7th postoperative day

The researcher will perform the neurocognitive level with a face-to-face interview with the moca test before surgery. In the postoperative period, the test will be repeated on the 7th day.

If the moca test is above 21, it will be considered normal. and the patient will be enrolled.

A decrease of 4 units in the moca test on the 7th postoperative day will be considered as postoperative cognitive dysfunction.
7th postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 21, 2020

Primary Completion (ACTUAL)

May 31, 2021

Study Completion (ACTUAL)

July 13, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (ACTUAL)

January 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-10/850 (OTHER: Ankara Oncology hospital clinical research ethics committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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