RecruitingNot ApplicableNCT06055387

Frailty Assessment and Intervention in Elderly Patients with Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy


Sponsor

Chang Gung Memorial Hospital

Enrollment

300 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Gastric cancer ranks among the top ten leading causes of death in Taiwan. Radical surgery is the sole curative method for gastric cancer. However, our previous research has revealed that elderly gastric cancer patients undergoing radical surgery face a significantly elevated risk of postoperative complications. Even after gastric cancer resection, only 70% of patients receive adjuvant chemotherapy, with a particularly low likelihood among those aged ≥ 65 to undergo such treatment. With the increasing elderly population in our country, an increasing number of elderly gastric cancer patients must decide whether they can withstand radical surgery for gastric cancer and whether to undergo adjuvant chemotherapy. Therefore, increasing the rates of elderly gastric cancer patients undergoing radical surgery and adjuvant chemotherapy, as well as improving the success rate of chemotherapy, has become a critical issue. Frailty has been a frequent topic in geriatric medicine in recent years. It involves assessing multifaceted aspects of physical functioning to determine an individual's frailty status, which can help predict the likelihood of severe side effects from medical interventions. International organizations like the American Cancer Society recommend frailty assessment for all elderly cancer patients before undergoing chemotherapy and corresponding interventions to address frailty. However, there is a lack of large-scale studies on frailty assessment and its practical clinical benefits in our population. This study is a prospective, open-label, randomized clinical trial designed to investigate the impact of geriatric intervention on the tolerance of surgery/chemotherapy in patients diagnosed with gastric cancer. As part of the study protocol, all enrolled patients will undergo a comprehensive frailty assessment within a window of 7 days before initiating their first treatment, followed by tailored geriatric interventions. The primary objective of this study is to assess and compare the effects of geriatric intervention on postoperative complications, chemotherapy tolerance, treatment-related toxicity, and overall quality of life among two distinct groups: frail and non-frail patients. Our research team aims to promote widespread frailty assessment and interventions with the following objectives: 1. Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery. 2. Enhance the tolerance and success rate of adjuvant chemotherapy for gastric cancer. These efforts ultimately aim to improve the survival prognosis of this patient group.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how to assess and address physical frailty in elderly patients with stomach cancer who are preparing for surgery followed by chemotherapy. The goal is to improve recovery outcomes and quality of life for older patients. **You may be eligible if...** - You are 65 years or older - You have been diagnosed with locally advanced (stage II or III) gastric cancer - You are scheduled for curative stomach cancer surgery - You plan to receive chemotherapy within 4–8 weeks after surgery - You are mentally alert and able to communicate **You may NOT be eligible if...** - You have cognitive impairment or cannot cooperate with assessments - You are receiving radiation therapy or additional surgery at the same time - You have multiple cancers requiring simultaneous treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFrailty intervention measures

Providing specialized guidance: * Physical Function and Fall History: * Prioritizing home safety for those with physical impairments. * Arranging rehab consultations when necessary. * Nutrition: * Assessing diets and offering education. * Pre-treatment nutritionist assessments. * Monitoring weight, intervening if \>5-10% loss, or \>10% loss. * Social Support: * Evaluating the needs of those without family support. * Referring to social services and introducing care resources. * Cognition: * Detecting cognitive issues, addressing reversible causes. * Assessing decision-making and medication self-administration. * Refer to specialists when needed. * Polypharmacy and Comorbidity: * Collecting medication data, ensuring adherence. * Noting chronic illnesses. * Collaborating with specialists or pharmacists for complex cases. * Psychological: * Providing weekly support for psychological concerns. * Refer to specialists for assessments and treatment options.


Locations(1)

Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan

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NCT06055387


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