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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.
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)
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:
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:
1.2.2 Indications for Discontinuing Nutritional Support:
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:
1.3.2 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:
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:
3. Exclusion Criteria
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Follow-up Group | Experimental | Participants in this group 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: Comprehensive evaluation of symptoms. Nutritional Assessment: Using internationally recognized tools such as NRS 2002 and PG-SGA. Psychological Assessment: Utilizing 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). |
|
| Standard Follow-up Group | Active Comparator | Participants in this group will receive standard postoperative follow-up care, which includes medical examinations and treatments as necessary. Nutritional and psychological assessments will only be conducted if deemed necessary by the patient or the healthcare provider. This group will serve as the control group for comparison with the enhanced follow-up group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Follow-up | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Improvement | Measurement of quality of life improvement in postoperative advanced gastric cancer patients using the EORTC QLQ-C30 questionnaire. The assessment will include various dimensions such as physical functioning, emotional well-being, social functioning, and overall health status. | Assessed every 6 weeks from the 4th week post-surgery until 6 months post-chemotherapy completion. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-Year Overall Survival Rate | The proportion of patients who are still alive 3 years after surgery. | 3 years post-surgery. |
| 5-Year Overall Survival Rate | The proportion of patients who are still alive 5 years after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Sun, MD, PHD | Contact | 18521064063 | 15111220073@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dazhi Xu, MD, PHD | Fudan University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12883115 | Background | Brown KW, Levy AR, Rosberger Z, Edgar L. Psychological distress and cancer survival: a follow-up 10 years after diagnosis. Psychosom Med. 2003 Jul-Aug;65(4):636-43. doi: 10.1097/01.psy.0000077503.96903.a6. | |
| 30944757 | Background | Guideline Committee of the Korean Gastric Cancer Association (KGCA), Development Working Group & Review Panel. Korean Practice Guideline for Gastric Cancer 2018: an Evidence-based, Multi-disciplinary Approach. J Gastric Cancer. 2019 Mar;19(1):1-48. doi: 10.5230/jgc.2019.19.e8. Epub 2019 Mar 19. No abstract available. |
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Individual participant data (IPD) that underlie the results reported in the article, after de-identification (text, tables, figures, and appendices), will be shared. This data will be made available to other researchers who provide a methodologically sound proposal.
Data will be available beginning 12 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal will be able to access the data. Proposals should be directed to the primary investigator. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Not provided
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|
| 5 years post-surgery. |
| 35914639 | Background | Lordick F, Carneiro F, Cascinu S, Fleitas T, Haustermans K, Piessen G, Vogel A, Smyth EC; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Gastric cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022 Oct;33(10):1005-1020. doi: 10.1016/j.annonc.2022.07.004. Epub 2022 Jul 29. No abstract available. |
| 24269077 | Background | Poulsen GM, Pedersen LL, Osterlind K, Baeksgaard L, Andersen JR. Randomized trial of the effects of individual nutritional counseling in cancer patients. Clin Nutr. 2014 Oct;33(5):749-53. doi: 10.1016/j.clnu.2013.10.019. Epub 2013 Nov 8. |
| 19797339 | Background | Andrew IM, Waterfield K, Hildreth AJ, Kirkpatrick G, Hawkins C. Quantifying the impact of standardized assessment and symptom management tools on symptoms associated with cancer-induced anorexia cachexia syndrome. Palliat Med. 2009 Dec;23(8):680-8. doi: 10.1177/0269216309106980. Epub 2009 Oct 1. |
| 20818875 | Background | Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678. |
| 33417481 | Background | Lu Z, Fang Y, Liu C, Zhang X, Xin X, He Y, Cao Y, Jiao X, Sun T, Pang Y, Wang Y, Zhou J, Qi C, Gong J, Wang X, Li J, Tang L, Shen L. Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial. J Clin Oncol. 2021 Mar 1;39(7):748-756. doi: 10.1200/JCO.20.01254. Epub 2021 Jan 8. |
| 22345712 | Background | Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012 Mar 7;104(5):371-85. doi: 10.1093/jnci/djr556. Epub 2012 Feb 15. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |