Geriatric Assessment for Lung Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: City of Hope Medical Center
Disqualifiers: Surgery planned, Symptomatic brain metastases, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Geriatric Assessment, Geriatric Evaluation, Comprehensive Geriatric Assessment, CGA for lung cancer?
Research shows that Comprehensive Geriatric Assessment (CGA) helps create personalized treatment plans for older cancer patients by identifying health issues that affect their ability to handle cancer treatment. It is also useful in predicting treatment outcomes and improving the quality of cancer care in older adults.
12345Is the Comprehensive Geriatric Assessment (CGA) safe for use in humans?
The Comprehensive Geriatric Assessment (CGA) is widely recommended for older adults, especially those with cancer, to guide treatment decisions. It is considered safe and is used to assess the overall health and vulnerability of elderly patients before and during cancer treatment.
678910How is the Geriatric Assessment treatment for lung cancer different from other treatments?
The Geriatric Assessment (CGA) is unique because it evaluates the overall health and specific needs of elderly lung cancer patients, helping to tailor treatment plans based on their fitness and frailty. This approach ensures that older patients receive the most appropriate care, whether it's standard treatment or supportive care, unlike traditional treatments that may not consider these individual factors.
5781112Eligibility Criteria
This trial is for older adults (60+) with unresectable non-small cell lung cancer planning to start a new treatment regimen within 4-6 weeks. It's open to those who can consent or have a proxy, understand English (or Spanish/Mandarin with available translation), and are treated at the participating site. Excluded are patients with planned surgery within 3 months, more than one metastatic site, or symptomatic brain metastases.Inclusion Criteria
I am 60 or older with non-small cell lung cancer that cannot be surgically removed.
I will start a new cancer treatment soon, which may include chemotherapy or similar drugs.
I have a single cancer spread outside the radiation area, like in the brain, lung, or adrenal gland.
+7 more
Exclusion Criteria
I am scheduled for surgery within the next 3 months or have had surgery before.
My cancer has spread to more than one part of my body.
I have brain metastases but no current symptoms, or they are treated and stable.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Geriatric Assessment and Management
Participants complete a geriatric assessment and receive GA-directed treatment recommendations
Prior to treatment initiation
1 visit (in-person)
Chemotherapy and Radiation Treatment
Participants receive chemotherapy and radiation therapy with GA-directed interventions
6 months
Multiple visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
20-26 weeks
3 visits (in-person)
Participant Groups
The study compares geriatric assessment-directed recommendations versus usual care in managing chemotherapy radiation therapy for older NSCLC patients. It aims to identify risk factors, reduce toxicity and functional decline, and improve quality of life by informing physicians' treatment decisions through comprehensive assessments.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (GA intervention)Experimental Treatment5 Interventions
Patients complete a geriatric assessment. Patients and physicians receive the geriatric assessment summary and assessment-based recommendations, which are provided prior to beginning chemotherapy and radiation, at the midpoint of chemotherapy and radiation treatment, and at the end of treatment. Patients also undergo blood and stool sample collection during screening and on study.
Group II: Arm II (usual care)Active Control5 Interventions
Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams, per usual care. Patients also undergo blood and stool sample collection during screening and on study.
Geriatric Assessment is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Geriatric Assessment for:
- Improving communication about age-related concerns in older cancer patients
- Enhancing patient and caregiver satisfaction with communication about age-related concerns
🇪🇺 Approved in European Union as Geriatric Assessment for:
- Identifying vulnerabilities in older cancer patients
- Informing cancer treatment decision-making
- Addressing impairments through appropriate interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State University Comprehensive Cancer CenterColumbus, OH
University of RochesterRochester, NY
City of Hope Medical CenterDuarte, CA
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Who Is Running the Clinical Trial?
City of Hope Medical CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Oncogeriatrics: an attempt to operational definition]. [2009]Comprehensive geriatric assessment (CGA) represents a multidisciplinary comprehensive evaluation of an older individual's functional status, comorbid medical conditions, cognition, psychological state, social support, nutritional status, and a review of the patient's medications. Initially, the use of a CGA in the care of older patients with cancer was based on an extrapolation of its ability to predict morbidity and mortality in the general geriatric population. More recently, however, accumulating data show the benefits of using a CGA particularly in patients with cancer to predict morbidity and mortality. Prospective trials evaluating the utility of a CGA to guide interventions to improve the quality of cancer care in older adults are justified.
Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer - a highly accessible model of care. [2021]Comprehensive Geriatric Assessment (CGA) has been proven to assist development of tailored treatment plans for older patients with cancer by identifying health issues affecting their ability to complete systemic therapy or cope with and recover from cancer treatment.
The comprehensive geriatric assessment in oncology: promises, pitfalls, and practicalities. [2015]Cancer commonly occurs in elderly patients. Treatment of cancer in this population is complex as the physiologic changes of aging impact treatment decisions, tolerance, and outcomes. A comprehensive geriatric assessment (CGA) is an objective means of assessing the global health of older patients, and evidence suggesting its promise as an aid to both decision making and outcome prediction in the oncology setting is growing. This article describes key studies that highlight the merits and limitations of the CGA for the evaluation of older patients with cancer. We also discuss the practical problems of its application, which may ultimately define the feasibility of its adoption into routine clinical practice.
Predicting outcome in older patients with cancer: Comprehensive geriatric assessment and clinical judgment. [2021]Comprehensive Geriatric Assessment (CGA) has been incorporated into geriatric oncology to prevent unfavorable outcome from anticancer treatment. This study determined the value of CGA and medical oncologist's clinical judgment in predicting unfavorable outcome and explored whether treatment decisions can be based on CGA.
Prognostic role of a comprehensive geriatric assessment on the management of elderly patients with advanced non-small cell lung cancer (NSCLC): a pooled analysis of two prospective phase II trials by the GFPC Group. [2022]The prognostic role of a comprehensive geriatric assessment (CGA) on the management of elderly patients with advanced-stage non-small cell lung cancer (NSCLC) remains to be established. The objective of this analysis was to determine the prognostic role of each CGA domain on overall survival (OS) among elderly patients with advanced-stage NSCLC.
Development of a cancer-specific Comprehensive Geriatric Assessment in a University Hospital in Spain. [2022]The Comprehensive Geriatric Assessment (CGA) is a key component of the treatment approach for older cancer patients. The goals of the current study were to develop a brief but non-self-administered cancer-specific geriatric assessment and to determine its feasibility, as measured by (1) the length of time to completion and (2) patient satisfaction.
Octogenarians treated for thoracic and lung cancers: Impact of comprehensive geriatric assessment. [2021]Lung cancer affects older and older old adults and is the leading cause of death by cancer. Comprehensive Geriatric Assessment (CGA) is recommended before and during cancer treatment to guide therapy management in this population.
Pilot study of the implementation of G8 screening tool, Cognitive screening assessment and Chemotherapy Toxicity assessment in older adults with cancer in a Tertiary University Hospital in Ireland. [2023]Comprehensive geriatric assessment (CGA) is recommended by international guidelines prior to initiation of systemic anti-cancer treatment (SACT). In practice, CGA is limited by time constraints, lack of resources and expert interpretation.
Use of a Comprehensive Geriatric Assessment for the Management of Elderly Patients With Advanced Non-Small-Cell Lung Cancer: The Phase III Randomized ESOGIA-GFPC-GECP 08-02 Study. [2022]Comprehensive geriatric assessment (CGA) is recommended to assess the vulnerability of elderly patients, but its integration in cancer treatment decision making has never been prospectively evaluated. Here, in elderly patients with advanced non-small-cell lung cancer (NSCLC), we compared a standard strategy of chemotherapy allocation on the basis of performance status (PS) and age with an experimental strategy on the basis of CGA.
Identifying an accurate pre-screening tool in geriatric oncology. [2022]The use of comprehensive geriatric assessment (CGA) in cancer patients older than 70 is recommended. Three pre-screening instruments have been proposed: the abbreviated comprehensive geriatric assessment (aCGA), the Vulnerable Elders Survey (VES-13), and the Groningen frailty index (GFI). The objective of the study was to identify the most efficient pre-screening tool that accurately determines individuals who may benefit from the entire CGA. A total of 113 elderly cancer patients were assessed by means of the aCGA, VES-13, GFI and the full CGA. The sensitivity, specificity of the three instruments was calculated, using the results from the entire CGA as the gold standard for the GFI and the VES-13. The aCGA was assessed whether each sub-component reliably predicts impairment on each sub-component of the full CGA. The majority of the participants were defined as being at risk of vulnerability: 68.14% had two or more impairments of the CGA or were cognitively impaired. The physical and disability questions are useful, but all other screening instruments miss too many cases.
[MANAGEMENT OF LUNG CANCER IN ELDERLY]. [2015]In France, more than 50% of patients diagnosed with lung cancer are elderly but recommendations about their management are scant. Several patient characteristics, as comorbidities, age-related physiological variations of the main body functions, or eventual long-term treatments, are predictive of survival and must consider for therapeutic decision. The Comprehensive Geriatric Assessment (CGA) is the best tool to evaluate elderly with lung cancer and to identify fit patients who are more likely to benefit from standard treatment from frail ones who are candidates for supportive care.
Older Patients Treated for Lung and Thoracic Cancers: Unplanned Hospitalizations and Overall Survival. [2021]Lung cancer affects older adults and is the leading solid tumor in terms of death. A Comprehensive Geriatric Assessment (CGA) is recommended before cancer treatment to guide therapy management.