Enhanced vs. Routine Follow-Up After Total Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

NCT06468969 | Not Yet Recruiting

• 1 other identifier: Support
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer; Total Gastrectomy; Postoperative Care; Quality of Life; Follow-up

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 3-Year Overall Survival Rate

  3 years post-surgery.

• 5-Year Overall Survival Rate

  5 years post-surgery.

Study Arms (2)

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).

Other: Enhanced Follow-up

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.

Other: Enhanced Follow-up

Interventions

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)

Enhanced Follow-up Group; Standard Follow-up Group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Related Publications (8)

• 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.

  PMID: 12883115 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.

  PMID: 30944757 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.

  PMID: 35914639 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.

  PMID: 24269077 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.

  PMID: 19797339 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.

  PMID: 20818875 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.

  PMID: 33417481 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.

  PMID: 22345712 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Dazhi Xu, MD, PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Sun, MD, PHD

CONTACT

18521064063; 15111220073@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 12 months and ending 36 months following article publication.
• Access Criteria: 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.