Effect of Geriatric Intervention in Frail Patients With Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Gastric, biliary and pancreatic cancer are commonly malignancies from gastro- intestinal tract in Taiwan. Because lack of specific symptoms at presentation and effective screening methodology, majority of these patients are diagnosed with metastatic or unresectable disease. Palliative chemotherapy is the good standard of therapy for patients with unresectable gastric, biliary and pancreatic cancer with benefit of prolong survival time and improve quality of life. Although the benefit of palliative chemotherapy seems to be the same for elderly and young cancer patients in clinical study, elderly patients are less frequently treated with chemotherapy or treated with suboptimal dosage. Elderly patients do not receive palliative chemotherapy because concerns of elder age, comorbidity, poor performance, lack of social/economic support and worry about treatment toxicities. The increase in life expectancy of the general population resulted in an increase in the number of elderly patients with cancers referred for palliative chemotherapy. Overtreatment may result in high mortality due to disregard of the aging patients' frailty; on the other hand, under-treatment resulting from over-concern regarding their ability to tolerate treatment, may compromise the survival outcome. Therefore, the appropriately selection of geriatric cancer patients for palliative chemotherapy has to be addressed urgently. Frailty is a progressive decline of physiological reserve leading to multiple functional disability and increases vulnerability to subsequent morbidity and mortality. Frailty is associated with treatment toxicity, chemotherapy tolerance, and survival outcome in clinical oncology. Recent randomized study reported geriatric intervention significantly improved chemotherapy tolerance in elderly patients. Therefore, the American Cancer Association has recommended routine geriatric assessment and intervention in oncogeriatric patients upon providing antitumor treatments. However, the effect of geriatric intervention on chemotherapy tolerance is seldom in Taiwan. This study is an open, randomized, prospective trial to evaluate the effect of geriatric intervention on chemotherapy tolerance in patients with unresectable gastric, biliary, and pancreatic cancer. All patients with receive frailty assessment within 7 days before initiation of first cycle palliative chemotherapy followed by geriatric intervention. The study aim is to compare for chemotherapy tolerance, treatment-related toxicity, and quality of life after completion 3 months chemotherapy treatment course between frail and non-frail patients. This study also aims to explore the effect of geriatric intervention of treatment tolerance, treatment-related toxicity, and quality of life in frail patients with gastric, biliary, and pancreatic cancer receiving palliative chemotherapy.

Official Title
-----------------
Effect of Geriatric Intervention in Frail Patients With Gastric, Biliary, and Pancreatic Cancer Receiving Palliative Chemotherapy

Conditions
-----------------
GI Cancer

Intervention / Treatment
-----------------
* Behavioral: Frailty intervention measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged sixty-five or older with metastatic or unresectable gastric, biliary, and pancreatic cancer. The patient must sign the informed consent form. Estimated survival period of more than 3 months. Conscious and able to communicate verbally or in writing, and willing to cooperate with invasive procedures. Exclusion Criteria: Patients with cognitive impairment or unable to cooperate with the interventional procedures as determined by the clinical physician. Patients receiving concurrent other anticancer treatments (radiation or surgery). Patients with multiple types of cancer requiring simultaneous treatment. Patients who have previously participated in this study during a prior chemotherapy regimen.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frail group<br>All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The frail group will receive management and recommendations based on the specific impairment domain. | Behavioral: Frailty intervention measures<br>* Providing management and recommendations based on the specific impairment domain. Assessment domain: Functional status Nutrition Comorbidity Mobility/Falls Mood Cognition Polypharmacy Social support.<br>|
| No Intervention: Non-frail group<br>All patients receive a frailty assessment within 7 days before initiating the first cycle of palliative chemotherapy, followed by geriatric intervention. Patients exhibiting impairments in at least two dimensions are considered frail. The non-frail group will not receive additional interventions, but the clinical physicians will still provide appropriate treatment based on the patient's condition. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the completion rate of chemotherapy in frail and non-frail patient groups three months after treatment initiation to assess whether frailty affects tolerance. |  | After completion 3 months chemotherapy treatment. | 
| Utilize CTCAE v5.0 to assess the grade and frequency of adverse events and treatment-related toxicity in frail and non-frail patient groups, and compare the differences between the two. |  | After completion 3 months chemotherapy treatment. | 
| Assess the level of quality of life in frail and non-frail patient groups before and after treatment using EORTC QLQ-C30 v3 and EORTC QLQ-ELD14. |  | After completion 3 months chemotherapy treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Comprehensive Geriatric Assessment (CGA), Chemotherapy, Outcome, Frailty