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

NCT06578858 | Not Yet Recruiting

• 1 other identifier: 81097524.9.0000.5208
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Salutogenesis; Sense of Coherence

Outcome Measures

Primary Outcomes (1)

• Resilience Levels and Clinical Outcomes

  1\) 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)

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

Interventions

Application of questionnaires BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who have undergone gastric cancer removal surgery and used immunonutrition in the pre or perioperative period

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Consultorios Guararapes

Jaboatão dos Guararapes, Pernambuco, 54330-230, Brazil

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Igor M Medeiros, Master's student

CONTACT

+5581991230315; araujo.medeiros@ufpe.br

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student at the Federal University of Pernambuco

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

BR (1)