Trial Title:
Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial
NCT ID:
NCT06468969
Condition:
Gastric Cancer
Total Gastrectomy
Postoperative Care
Quality of Life
Follow-up
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Enhanced Follow-up
Description:
Participants will receive comprehensive follow-up care starting from the 4th week
post-surgery. Every 3 weeks, they will undergo a thorough assessment that includes:
Symptom Assessment Nutritional Assessment (using NRS 2002 and PG-SGA) Psychological
Assessment (using DT, GAD-7, FCR-7, ISI, PHQ-9)
Arm group label:
Enhanced Follow-up Group
Arm group label:
Standard Follow-up Group
Summary:
The goal of this clinical trial is to compare the effectiveness of enhanced follow-up
with standard follow-up in postoperative patients with advanced gastric cancer who have
undergone radical gastrectomy. The main questions it aims to answer are:
Can enhanced follow-up alleviate symptom burden and improve quality of life? What is the
impact of enhanced follow-up on overall survival rates at 3 and 5 years post-surgery?
Participants will:
Be randomly assigned to either the enhanced follow-up group or the standard follow-up
group.
Undergo comprehensive symptom, nutritional, and psychological assessments every 3 weeks
(enhanced follow-up group).
Receive routine postoperative follow-up including medical examinations and treatments as
needed, with additional assessments only when necessary (standard follow-up group).
Researchers will compare the enhanced follow-up group with the standard follow-up group
to see if enhanced follow-up can improve quality of life and increase overall survival
rates at 3 and 5 years post-surgery.
Outcomes will be measured using the EORTC QLQ-C30 quality of life questionnaire and
overall survival rates. This prospective, single-center, randomized controlled clinical
trial will span 5 years from the approval by the institutional ethics committee and will
include 158 patients.
Detailed description:
1. Study Design and Methods 1.1 Study Design: This study is designed as a randomized
controlled trial, with randomization implemented through an online clinical
database. In this study, "enhanced follow-up" refers to comprehensive assessments
every 3 weeks post-surgery, including symptom, nutritional, and psychological
evaluations. "Standard follow-up" follows routine clinical practice, providing
assessments only when necessary.
Experimental Group (Enhanced Follow-up Group) 1) Patients will undergo comprehensive
assessments every 3 weeks post-surgery. 2) Nutritional Assessment: Using internationally
recognized tools such as NRS 2002 and PG-SGA.
3) Psychological Assessment: Using tools such as the Distress Thermometer (DT),
Generalized Anxiety Disorder 7-item scale (GAD-7), Fear of Cancer Recurrence 7-item
scale (FCR-7), Insomnia Severity Index (ISI), and the Patient Health Questionnaire
9-item depression scale (PHQ-9).
Control Group (Standard Follow-up Group)
1. Patients will receive standard postoperative follow-up, including medical
examinations and treatments as needed.
2. Nutritional and psychological assessments will be conducted only when deemed
necessary by the patient or the healthcare provider.
For all patients, quality of life will be assessed using the EORTC QLQ-C30 questionnaire
from 4 weeks post-surgery, every 6 weeks until 6 months post-chemotherapy. Additionally,
3-year and 5-year overall survival rates will be used to evaluate patient prognosis.
Adverse events will be monitored and recorded, and treatment strategies will be adjusted
as needed to ensure patient safety and study efficacy.
1.2 Nutritional Intervention
1.2.1 Nutritional Assessment Protocol:
Nutritional risk screening and comprehensive nutritional assessment will be conducted by
dietitians, including Nutritional Risk Screening 2002 (NRS 2002), Patient-Generated
Subjective Global Assessment (PG-SGA), dietary habits, and blood tests. Based on scores
and clinical data, patients will be categorized into three groups:
1. Good nutrition or mild malnutrition group: Dietary guidance without delaying
chemotherapy, with weekly nutritional risk screening.
2. Moderate malnutrition group: Dietary counseling and enteral nutrition support
without delaying chemotherapy.
3. Severe malnutrition group: Counseling and nutrition support for 1-2 weeks before
starting cancer treatment, continuing nutrition support during treatment.
NRS 2002: Includes disease score, nutritional impairment score, and age score,
recommended by ESPEN and CSPEN for hospitalized patients. Patients are classified as at
nutritional risk (score ≥ 3) or not at risk (score < 3).
PG-SGA: Designed for cancer patients, includes self-reported questionnaire and clinical
assessment, with scores categorized as well-nourished (0-1), suspected malnutrition
(2-3), moderate malnutrition (4-8), and severe malnutrition (≥9). In this study, NRS 2002
≥ 3 or PG-SGA ≥ 4 indicates need for nutritional intervention.
1.2.2 Nutritional Support Protocol:
1. Development of Nutritional Support Plan: Based on the "Chinese Medical Association
Guidelines for Parenteral and Enteral Nutrition" and individual clinical cases.
2. Nutritional Supply Standards: Target daily nutritional intake (including diet and
parenteral/enteral nutrition support) set at 20-30 kcal/kg and 1-1.5 g/kg protein
based on standard body weight.
3. Preference for Enteral Nutrition: Unless unable to achieve 60% target energy intake
within 7 days, enteral nutrition is preferred; patients with contraindications
should receive total parenteral nutrition.
4. Enteral Nutrition Formulation: Nutrison is the preferred formula. For intolerance or
chronic disease complications, appropriate formulas such as Leskon or Abbott's
Glucerna will be selected.
5. Calculation of Enteral Nutrition Support Level: If oral intake is reduced by
1/3-1/2, provide 2-3 cups/day (400-600 kcal) orally or via tube feeding. If reduced
by more than 1/2, provide 3-5 cups/day (600-1000 kcal).
6. Preparation and Administration of Enteral Nutrition: Mix 9 scoops of Nutrison in 180
ml of warm water to make 1 cup of 1.0 kcal/ml nutritional solution, administered in
divided doses (50-200 ml) daily. Initial volume should be half the prescribed
amount, gradually increasing based on tolerance. Follow instructions for other
brands.
7. Gradual Reduction or Discontinuation of Enteral/Parenteral Nutrition: When oral
intake and enteral nutrition support meet 60% of nutritional needs, gradually reduce
or discontinue support.
1.2.2 Indications for Discontinuing Nutritional Support:
1. Severe complications or contraindications to enteral nutrition.
2. Normal oral intake meeting daily nutritional needs.
3. Patient condition worsens, hemodynamic instability, or other contraindications.
1.2.4 Evaluation of Nutritional Support Effectiveness: Nutritional follow-up: The
Nutritional Support Team (NST) will track patients' nutritional status every 3-4 weeks
and adjust plans based on updates and tolerance until chemotherapy completion. Follow-up
includes dietary and nutritional intake, weight changes, gastrointestinal symptoms or
complications, and laboratory tests (serum electrolytes, liver/kidney function, blood
glucose, lipids). Data will be recorded in case report forms (CRFs).
1.3 Psychological Intervention 1.3.1 Psychological Assessment Protocol:
1. Distress Thermometer (DT): A single-item scale from 0 (no distress) to 10 (extreme
distress). The problem list covers five areas: practical, communication, emotional,
physical, and spiritual/religious problems. A score ≥ 4 indicates high psychological
distress.
2. Generalized Anxiety Disorder 7-item scale (GAD-7): Contains 7 items to assess the
frequency of anxiety symptoms over the past two weeks, ranging from 0 (not at all)
to 3 (nearly every day). A total score of 21, with scores ≥ 10 indicating possible
clinically significant anxiety.
3. Fear of Cancer Recurrence 7-item scale (FCR-7): Specifically assesses the fear of
cancer recurrence in survivors, with scores ranging from 0 (not at all) to 4 (a
lot). A total score of 28, with higher scores indicating greater fear and potential
need for professional support.
4. Insomnia Severity Index (ISI): Contains 7 items to evaluate insomnia severity, its
impact on daily functioning, and the patient's perception of insomnia. Scores range
from 0 (no problem) to 4 (very severe), with total scores ≥ 15 indicating severe
insomnia.
5. Patient Health Questionnaire-9 (PHQ-9): Assesses depression severity over the past
two weeks, with scores ranging from 0 (not at all) to 3 (nearly every day). A total
score of 27, with higher scores indicating more severe depression.
1.3.2 Psychological Intervention Plan:
Assessments will be conducted every 3-4 weeks post-gastrectomy until 6 months
post-surgery. Psychologists will help patients cope with the psychosocial impact of
cancer treatment and provide further counseling as needed for patients and their family
members.
1.3.2 Psychological Intervention:
1. Family Therapy: Interventions include "exploring family cohesion," "communicating
thoughts and feelings," and "managing family conflicts." Typically involves three
stages: 1) Identifying specific family issues and developing solutions; 2) Actual
intervention; 3) Summary of psychological intervention. Frequency and duration of
interventions will be adjusted based on each family's needs.
2. Individual Therapy: Principles include individualized psychological interventions
based on clinical practice guidelines, with additional individual therapy provided
during family interventions for those needing extra support.
3. Psychopharmacological Intervention: For patients meeting psychiatric diagnostic
criteria (ICD-10 and DSM-IV), relevant psychopharmacological interventions (for
anxiety, depression, insomnia, and adjustment disorders) will be provided.
Medication will be offered to both intervention and control groups as deemed
necessary by patients, family members, or attending physicians.
2. Withdrawal/Early Termination Criteria
Patients may voluntarily withdraw from the study at any time. Investigators may also
decide to withdraw patients based on specific circumstances and medical judgment,
ensuring the best interests of the patients. Reasons for withdrawal include:
1. Voluntary Withdrawal: Participants may withdraw at any time without providing a
reason.
2. Non-compliance: Participants failing to adhere to study requirements, such as
missing follow-ups or not completing necessary questionnaires.
3. Adverse Events: Occurrence of severe adverse events or other health issues related
to the study, determined by the research doctor to be in the participant's best
interest.
4. Disease Progression: Significant worsening of the participant's disease, preventing
continued study participation.
5. Other Medical Reasons: Based on medical judgment, the research doctor determines
that continuing participation is not suitable.
6. Loss to Follow-up: Participants lost to follow-up during the study, preventing
further monitoring.
3. Exclusion Criteria
1. Patients not completing the scheduled treatment plan or follow-up.
2. Incomplete efficacy evaluation data, preventing effective assessment.
3. Efficacy evaluation not conducted as per the planned protocol, affecting result
accuracy.
4. Non-compliance and termination cases should be followed up and analyzed according to
the "intention-to-treat" (ITT) principle.
4. Follow-up Plan Establish a dedicated follow-up mechanism. Follow-up requirements:
Every 3 months for the first 2 years post-surgery, then every 6 months until study
completion. Follow-up includes lab tests (blood count, liver/kidney function, tumor
markers), imaging (chest X-ray or CT, abdominal CT scan + enhancement, neck and
supraclavicular lymph node ultrasound), and annual endoscopic examinations.
5. Follow-up Endpoints
1. Patient withdraws from the study.
2. Change in treatment due to complications or other conditions.
3. Patient death due to various causes.
4. Completion of the study period.
5. Loss to follow-up due to various reasons.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age: 18 to 72 years at the time of informed consent.
- Underwent radical total gastrectomy.
- Postoperative pathology confirmed advanced adenocarcinoma of the stomach or
gastroesophageal junction.
- Estimated survival time ≥3 months.
- Good cognitive and reading abilities, capable of completing questionnaires.
- Willing and able to provide written informed consent for the study.
Exclusion Criteria:
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Patients with other malignancies.
- Clinically significant cardiovascular disease, such as heart failure (NYHA III-IV),
uncontrolled coronary artery disease, cardiomyopathy, arrhythmia, or hypertension.
- Neurological or psychiatric disorders affecting cognitive function, including
central nervous system metastasis.
- Active infectious diseases, such as active hepatitis or tuberculosis.
- Uncontrolled systemic diseases, such as poorly controlled diabetes.
- Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or
evidence of interstitial lung disease on baseline chest X-ray/CT.
- Pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
72 Years
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06468969
