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NCT Number: NCT06578858

Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastrectomy: a Multidimensional Analysis

To conduct this research, the following guiding question was formulated: "Can immunonutrition, combined with the assessment of SOC and resilience, provide a broad view of the physical and psychological results during the treatment and recovery process of patients undergoing gastric cancer surgery?". This led to the formulation of the following hypothesis: "Patients who received immunonutrition and who have higher levels of resilience and sense of coherence will tend to exhibit more favorable clinical and laboratory outcomes for recovery after gastric cancer surgery.

In order to answer the question and test the study hypothesis, the general objective consisted of:

To evaluate the association of clinical and laboratory outcomes with the sense of coherence and resilience of patients undergoing gastric cancer surgery who received immunonutrition.

In view of this general objective, the following specific objectives were formulated:

* To evaluate the levels of resilience and sense of coherence in patients undergoing gastric cancer surgery who received immunonutrition. * Analyze the results of blood count and C-Reactive Protein (CRP) in patients who received immunonutrition after gastric cancer surgery. * Identify the association between resilience levels, sense of coherence, blood count and CRP values with clinical outcomes, such as length of hospital stay and wound recovery, in patients undergoing gastric cancer surgery who used immunonutrition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult or elderly patients (age ≥ 18 years) Treated at Consultório Guararapes Underwent surgery to remove gastric cancer Used immunonutrition in the pre, post, or perioperative period Applicable to both sexes

Exclusion criteria

Pre-existing hematologic diseases that may affect blood count results History of drug abuse (legal and/or illegal) Presence of other neoplasms History of psychological disorders affecting ability to respond to study questionnaires

Treatment and study plan

Application of questionnaires

Behavioral

Application of SOC-13 and BRS questionnaires in patients after gastric cancer surgery

Primary outcomes

  1. Resilience Levels and Clinical Outcomes

    Time frame: Questionnaires to assess resilience and sense of coherence will be administered once, after gastric cancer removal surgery.

    • Separate outcome measures:

    Levels of resilience Title: Measure of resilience level Description: Resilience will be measured using the Resilience Scale, with scores ranging from (1.00 - 2.99) = Low; (3.00 - 4.30) = Normal; (4.31 - 5.00) = High Unit of measurement: Score Measurement tool: Brief Resilience Scale (BRS)

    Sense of coherence Title: Measure of sense of coherence Description: Sense of coherence will be assessed using the Sense of coherence Scale, with a median of 35 Unit of measurement: Median (35) Measurement tool: Sense of coherence scale questionnaire (SOC-13)

Study contacts

Contact information is provided by the study sponsor or research team.

Igor M Medeiros, Master's student

CONTACT

[email protected]

+5581991230315

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastric Cancer Surgery: a Multidimensional Analysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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