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Postoperative Cognitive DysfunctionNCT04701801

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

An observational study of Postoperative Cognitive Dysfunction and Preoperative Anxiety, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
MoCA test
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Oct 2020to 13 Jul 2021
How long will I take part?
8 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Alcohol addiction
  • Clinical diagnosis of psychiatric disease
  • Cervical surgery history
  • Inability to comply with the questionnaire or study
  • Chemotherapy history

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

    Ankara

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
MoCA test
Medical subject headings
Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoCA testDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7th postoperative day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021
  2. Study start21 Oct 2020
  3. Primary completion31 May 2021
  4. Study completion13 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
8 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04701801
Sponsor's protocol ID
2020-10/850
Other IDs
2020-10/850
Status last verified
Oct 2022
First submitted
5 Jan 2021
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22727334

  • 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.

    PubMed 30348620

  • 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.

    PubMed 24236147

  • 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.

    PubMed 23891039

  • 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.

    PubMed 15162149

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Cognitive Dysfunction and Preoperative Anxiety, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 7th postoperative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04701801, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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