Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-16
Brief Title:
Enhanced vs Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer A Randomized Controlled Trial
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Prospective Single-Center Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 11 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
12 Nutritional Intervention
121 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
122 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 parenteralenteral nutrition support set at 20-30 kcalkg and 1-15 gkg 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 Abbotts Glucerna will be selected
5 Calculation of Enteral Nutrition Support Level If oral intake is reduced by 13-12 provide 2-3 cupsday 400-600 kcal orally or via tube feeding If reduced by more than 12 provide 3-5 cupsday 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 10 kcalml 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 EnteralParenteral Nutrition When oral intake and enteral nutrition support meet 60 of nutritional needs gradually reduce or discontinue support
122 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
124 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 liverkidney function blood glucose lipids Data will be recorded in case report forms CRFs
13 Psychological Intervention 131 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 spiritualreligious 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 patients 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
132 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
132 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 familys 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 WithdrawalEarly 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 participants best interest
4 Disease Progression Significant worsening of the participants 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 liverkidney 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
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
12 Nutritional Intervention
121 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
122 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 parenteralenteral nutrition support set at 20-30 kcalkg and 1-15 gkg 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 Abbotts Glucerna will be selected
5 Calculation of Enteral Nutrition Support Level If oral intake is reduced by 13-12 provide 2-3 cupsday 400-600 kcal orally or via tube feeding If reduced by more than 12 provide 3-5 cupsday 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 10 kcalml 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 EnteralParenteral Nutrition When oral intake and enteral nutrition support meet 60 of nutritional needs gradually reduce or discontinue support
122 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
124 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 liverkidney function blood glucose lipids Data will be recorded in case report forms CRFs
13 Psychological Intervention 131 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 spiritualreligious 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 patients 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
132 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
132 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 familys 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 WithdrawalEarly 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 participants best interest
4 Disease Progression Significant worsening of the participants 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 liverkidney 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None