Gastric CancerNCT06578858
Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastrectomy: a Multidimensional Analysis
An observational study of Gastric Cancer and Salutogenesis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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?". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Salutogenesis, Sense of Coherence
- What is being tested?
- Application of questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2024to Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who have undergone gastric cancer removal surgery and used immunonutrition in the pre or perioperative period
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Consultorios Guararapes
Jaboatão dos Guararapes, Pernambuco, 54330-230
Emanuel S Sarinho, Doctor, +55 81 8881-4801, usuario101122@gmail.com
About this study
Official title: Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastric Cancer Surgery: 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:
Read more
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
- Being tested
- Application of questionnaires
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of questionnairesBehavioural
Application of SOC-13 and BRS questionnaires in patients after gastric cancer surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience Levels and Clinical Outcomes
- 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)
Measured: Questionnaires to assess resilience and sense of coherence will be administered once, after gastric cancer removal surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Gabriel Araújo Medeiros, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578858
- Sponsor's protocol ID
- 81097524.9.0000.5208
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunonutrition and Psychosocial Factors in the Recovery of Patients After Gastric Cancer Surgery: a Multidimensional Analysis
- ClinicalTrials.gov ID
- NCT06578858
- Acronym / sponsor ID
- 81097524.9.0000.5208
- Conditions
- Gastric Cancer, Salutogenesis, Sense of Coherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who have undergone gastric cancer removal surgery and used immunonutrition in the pre or perioperative period
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of questionnairesApplication of SOC-13 and BRS questionnaires in patients after gastric cancer surgery | Behavioural | – |
Primary outcome
Resilience Levels and Clinical Outcomes
Time frame: Questionnaires to assess resilience and sense of coherence will be administered once, after gastric cancer removal surgery.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Salutogenesis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor M Medeiros, Master's student (+5581991230315, araujo.medeiros@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience Levels and Clinical Outcomes (time frame: Questionnaires to assess resilience and sense of coherence will be administered once, after gastric cancer removal surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2024.