Clinical trial · Interventional

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

A Prospective, Single-Center, Randomized Controlled Trial Comparing Enhanced Follow-up With Standard Follow-up in Post-Gastrectomy Patients With Advanced Gastric Cancer

NCT06468969CI-TRIAL-00078124not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Follow-up	—	UNRESOLVED	—
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Postoperative Care	—	UNRESOLVED	—
Quality of Life	—	UNRESOLVED	—
Total Gastrectomy	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Enhanced Follow-up	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Enhanced Follow-up Group
description
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).
interventionNames
1. Other: Enhanced Follow-up
type
ACTIVE_COMPARATOR
label
Standard Follow-up Group
description
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.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 72 Years

Show eligibility criteria text

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.

References

Publications (8)

BACKGROUNDBrown 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
BACKGROUNDGuideline 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
BACKGROUNDLordick 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
BACKGROUNDPoulsen 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
BACKGROUNDAndrew 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
BACKGROUNDTemel 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