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

NCT04701801 | Completed

• 1 other identifier: 2020-10/850
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Cognitive Dysfunction; Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• 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)

  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

Interventions

MoCA test DIAGNOSTIC_TEST

Preoperative MoCA test and State-Trait Anxiety Inventory Test (STAI FORM ) questionnaire form will be filled in female patients between the ages of 18-65 by making a one-on-one interview with the patient and the MoCA test will be applied in the early postoperative period (1st week) to ensure its relationship with POCD will be checked.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The preoperative anxiety rate was found twice as high in female patients compared to male patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Cerebral ischemia or hemorrhage history
• Clinical diagnosis of Neurodegenerative disease
• Clinical diagnosis of carotid stenosis,
• The score 20 or less in the Moca test,
• Carotid endarterectomy history
• Aneurysm surgery history
• Alcohol addiction
• Clinical diagnosis of psychiatric disease
• Cervical surgery history
• Inability to comply with the questionnaire or study
• Chemotherapy history

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: prevalence rates by cancer type, gender, and age. J Affect Disord. 2012 Dec 10;141(2-3):343-51. doi: 10.1016/j.jad.2012.03.025. Epub 2012 Jun 21.

  PMID: 22727334 BACKGROUND

• Alam A, Hana Z, Jin Z, Suen KC, Ma D. Surgery, neuroinflammation and cognitive impairment. EBioMedicine. 2018 Nov;37:547-556. doi: 10.1016/j.ebiom.2018.10.021. Epub 2018 Oct 19.

  PMID: 30348620 BACKGROUND

• Peng L, Xu L, Ouyang W. Role of peripheral inflammatory markers in postoperative cognitive dysfunction (POCD): a meta-analysis. PLoS One. 2013 Nov 13;8(11):e79624. doi: 10.1371/journal.pone.0079624. eCollection 2013.

  PMID: 24236147 BACKGROUND

• Camacho A. Is anxious-depression an inflammatory state? Med Hypotheses. 2013 Oct;81(4):577-81. doi: 10.1016/j.mehy.2013.07.006. Epub 2013 Jul 26.

  PMID: 23891039 BACKGROUND

• Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.

  PMID: 15162149 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: October 21, 2020
• Primary Completion: May 31, 2021
• Study Completion: July 13, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

TU (1)