Actively Recruiting
Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Led by Chang Gung Memorial Hospital · Updated on 2025-02-13
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
M
Ministry of Health and Welfare, Taiwan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gastric cancer is a leading cause of death in Taiwan, particularly among elderly patients. Radical surgery is the only curative option, but older patients face higher risks of postoperative complications. Many elderly patients also have low rates of receiving adjuvant chemotherapy after surgery. This research aims to study the impact of a comprehensive geriatric intervention on surgery and chemotherapy tolerance in elderly gastric cancer patients, focusing on reducing complications and improving treatment success. Patients enrolled will receive a frailty assessment within 7 days before starting treatment. Those identified as frail, based on impairments in multiple areas, will receive targeted geriatric interventions including physical function support, nutritional guidance, social support, cognitive assessment, medication review, and psychological help. Non-frail patients will receive usual clinical care without additional interventions. This open-label, randomized study compares these two groups to evaluate the effects of tailored interventions. During the study, researchers will monitor surgical complications and chemotherapy-related toxicity using established grading systems. Participants will be assessed for adverse events, treatment tolerance, and overall quality of life up to several months after treatment begins. The trial also plans to compare survival outcomes between frail and non-frail groups over a year. The total involvement includes frailty assessment, geriatric management, and follow-up evaluations to improve treatment outcomes for elderly gastric cancer patients.
CONDITIONS
Brief Title
Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 years or older with locally advanced (stage II or III) gastric cancer
- Preparing for curative gastric cancer surgery and scheduled for adjuvant chemotherapy within 4-8 weeks after surgery
- Able to provide signed informed consent
- Estimated survival of more than 3 months
- Conscious and able to communicate verbally or in writing, willing to cooperate with invasive procedures
You will not qualify if you...
- Patients with cognitive impairment or unable to cooperate with interventions as determined by a clinical physician
- Patients receiving other anticancer treatments such as radiation or surgery concurrently
- Patients with multiple types of cancer requiring simultaneous treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days before initiating treatment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for frailty assessment
Duration - Up to 3 months during surgery and adjuvant chemotherapy treatment
Participants receive frailty intervention measures including physical, nutritional, social, cognitive, medication, and psychological support based on assessment results.
Weekly visits for psychological support and ongoing intervention as needed
Duration - Up to 1 year after treatment initiation
Participants are followed to assess surgical complications, adverse events, and overall survival after treatment completion.
Periodic follow-up visits as scheduled by clinical team
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital
Taoyuan, Taiwan, Taiwan, 330
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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