Clinical trial NCT04701801: Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients
Official title: Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Preoperative Anxiety
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 7th postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital clinic of Anesthesiology and Reanimation
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.