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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Frailty intervention measures
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring Frailty, Comprehensive Geriatric Assessment (CGA), Outcome, Radical surgery, Adjuvant chemotherapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged sixty-five or older with locally advanced (stage II and stage III) gastric cancer, preparing for curative gastric cancer surgery and scheduled to receive adjuvant chemotherapy within 4-8 weeks postoperatively, either as outpatients or inpatients. Patients must provide signed informed consent. Estimated survival 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.

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Frail group

Non-frail group

Arm Description

All patients receive a frailty assessment within 7 days before initiating treatment, 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.

All patients receive a frailty assessment within 7 days before initiating treatment, 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.

Outcomes

Primary Outcome Measures

Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system.
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.

Secondary Outcome Measures

Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed by the Clavien-Dindo grading system or CTCAE v5.0, occurring in frail groups three months after initiating treatment.
The frail group will receive management and recommendations based on the specific impairment domain.
To compare overall survival between two distinct groups: frail and non-frail patients.

Full Information

First Posted
August 29, 2023
Last Updated
September 20, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT06055387
Brief Title
Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Official Title
Frailty Assessment and Intervention in Elderly Patients With Gastric Cancer Receiving Gastrectomy and Adjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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: Reduce the probability of postoperative complications among elderly gastric cancer patients receiving surgery. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Frailty, Comprehensive Geriatric Assessment (CGA), Outcome, Radical surgery, Adjuvant chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frail group
Arm Type
Experimental
Arm Description
All patients receive a frailty assessment within 7 days before initiating treatment, 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.
Arm Title
Non-frail group
Arm Type
No Intervention
Arm Description
All patients receive a frailty assessment within 7 days before initiating treatment, 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.
Intervention Type
Behavioral
Intervention Name(s)
Frailty intervention measures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparing surgical complications between frail and non-frail patients using the Clavien-Dindo grading system.
Time Frame
After completion 3 months treatment.
Title
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.
Time Frame
After completion 3 months treatment.
Secondary Outcome Measure Information:
Title
Examine whether implementing appropriate frailty interventions can reduce the likelihood of adverse events, as assessed by the Clavien-Dindo grading system or CTCAE v5.0, occurring in frail groups three months after initiating treatment.
Description
The frail group will receive management and recommendations based on the specific impairment domain.
Time Frame
After completion 6 months treatment.
Title
To compare overall survival between two distinct groups: frail and non-frail patients.
Time Frame
up to 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged sixty-five or older with locally advanced (stage II and stage III) gastric cancer, preparing for curative gastric cancer surgery and scheduled to receive adjuvant chemotherapy within 4-8 weeks postoperatively, either as outpatients or inpatients. Patients must provide signed informed consent. Estimated survival 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.
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
330
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Chi Chou
Phone
+8863281200
Ext
8426
Email
f12986@cgmh.org.tw

12. IPD Sharing Statement

Learn more about this trial

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

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