Geriatric Assessment for Lung Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Surgery planned, Symptomatic brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a geriatric assessment (a detailed health check-up for older adults) can help doctors create better treatment plans for older patients with non-small cell lung cancer (NSCLC). The goal is to reduce chemotherapy and radiation side effects while improving patients' overall quality of life. The trial compares two approaches: one where doctors receive detailed assessment results and recommendations, and another where they do not. Suitable participants have NSCLC, are 60 or older, and plan to start a new cancer treatment soon. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment strategies for older adults with 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 prior data suggests that this geriatric assessment is safe for older patients with lung cancer?

Research has shown that geriatric assessments (GA) aid in managing treatment for older cancer patients, including those with non-small cell lung cancer (NSCLC). These assessments help doctors identify patients at higher risk for issues like treatment side effects. Studies have demonstrated that geriatric assessments can customize treatment plans to reduce risks and improve outcomes.

A comprehensive geriatric assessment (CGA) is considered the best approach. It is often used to identify older cancer patients who might experience more severe treatment side effects. This helps doctors make informed decisions about cancer therapies. By identifying specific risks, the CGA allows doctors to adjust treatments to better suit the patient's needs, potentially leading to fewer side effects and better overall health during treatment.

In summary, geriatric assessments are well-received and play a key role in making cancer treatments safer for older adults. They help doctors balance the benefits and risks of chemotherapy and other treatments, aiming to improve patients' quality of life while minimizing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using geriatric assessment in treating lung cancer because it personalizes care for older adults. Unlike the standard approach that doesn't fully integrate detailed geriatric information, this method provides comprehensive insights into a patient's health status, which guides treatment decisions. By tailoring chemotherapy and radiation strategies based on these assessments, doctors can potentially improve outcomes and reduce side effects for elderly patients with lung cancer. This focus on individual health factors represents a shift toward more personalized and precise cancer care.

What evidence suggests that this geriatric assessment is effective for improving outcomes in older patients with non-small cell lung cancer?

This trial will compare the effects of a geriatric assessment (GA) intervention with usual care for older adults with lung cancer. Research has shown that geriatric assessments can improve health outcomes for older adults with cancer. Studies have found that GA helps doctors select treatments that result in fewer chemotherapy side effects. Randomized controlled trials (RCTs) have demonstrated that GA enhances health outcomes, including quality of life and the ability to complete chemotherapy. Evidence also suggests that GA can reduce unexpected hospital visits and improve survival rates. These assessments identify risk factors, enabling more personalized and effective care. ^{3 6 7 8 9}

Who Is on the Research Team?

Arya Amini

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Assessment

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm I (GA intervention) Experimental Treatment 5 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 Control 5 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

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 194 elderly patients (average age 77) with advanced non-small cell lung cancer, performance status and comorbidities were identified as key predictors of overall survival, highlighting the importance of comprehensive geriatric assessment in treatment planning.

Specifically, performance status and the Charlson comorbidity score were found to be independently prognostic factors for overall survival, suggesting that these assessments can help tailor treatment strategies for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Le Caer, H., Borget, I., Corre, R., et al.[2022]

A new cancer-specific Comprehensive Geriatric Assessment (CGA) was developed for older cancer patients, which was completed by 99 participants with a mean age of 78.65 years in an average time of 12.9 minutes.

Most patients found the CGA to be satisfactory in length and easy to complete, indicating its feasibility as a tool for assessing the needs of older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a cancer-specific Comprehensive Geriatric Assessment in a University Hospital in Spain. Molina-Garrido, MJ., Guillén-Ponce, C.[2022]

In a study of 113 elderly cancer patients, it was found that a significant 68.14% were at risk of vulnerability, indicating a high prevalence of impairments among this population.

The abbreviated comprehensive geriatric assessment (aCGA) showed promise in predicting impairments, but the other pre-screening tools (VES-13 and GFI) were less effective, missing many cases that could benefit from a full comprehensive geriatric assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying an accurate pre-screening tool in geriatric oncology. Kellen, E., Bulens, P., Deckx, L., et al.[2022]

Over 50% of lung cancer patients in France are elderly, highlighting the need for tailored management strategies for this age group.

The Comprehensive Geriatric Assessment (CGA) is essential for evaluating elderly lung cancer patients, helping to distinguish between those who can benefit from standard treatments and those who may require supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MANAGEMENT OF LUNG CANCER IN ELDERLY]. Leduc, C., Quoix, E.[2015]

In a study of 228 older patients with lung cancer, factors such as male gender, systemic therapy, and a history of falls were linked to a higher risk of unplanned hospitalizations within the first three months after treatment.

The G8 score and handgrip strength were identified as significant predictors of overall survival, with lower scores and weaker grip strength associated with decreased survival rates in older adults undergoing treatment for thoracic tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Patients Treated for Lung and Thoracic Cancers: Unplanned Hospitalizations and Overall Survival. Couderc, AL., Tomasini, P., Nouguerède, E., et al.[2021]

In a study involving 494 elderly patients with advanced non-small-cell lung cancer, treatment allocation based on comprehensive geriatric assessment (CGA) did not improve treatment failure-free survival (TFFS) or overall survival (OS) compared to standard methods based on performance status and age.

However, patients in the CGA arm experienced significantly lower overall toxicity and fewer treatment failures due to toxicity, suggesting that while CGA may not enhance survival outcomes, it can lead to a safer treatment experience for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Corre, R., Greillier, L., Le Caër, H., et al.[2022]

A study involving 228 lung cancer patients aged 70 and older found that octogenarians (≥80 years) had similar overall survival rates compared to younger patients (70-79 years) despite differences in treatment approaches.

Handgrip strength was identified as a key indicator of health in octogenarians, suggesting that assessing muscle strength during Comprehensive Geriatric Assessment (CGA) can enhance treatment management for older patients with lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octogenarians treated for thoracic and lung cancers: Impact of comprehensive geriatric assessment. Couderc, AL., Tomasini, P., Rey, D., et al.[2021]

In a pilot study of 63 older cancer patients (average age 73), over 80% were found to be at high risk for chemotherapy toxicity, indicating a significant need for comprehensive geriatric assessment (CGA) before starting systemic anti-cancer treatment.

The study revealed that frailty and cognitive impairment were prevalent among participants, with 83% scoring ≤14 on the G8 frailty assessment and 21% showing cognitive impairment on the Mini-Cog, highlighting the importance of evaluating these factors in older adults undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. AlSendi, M., Flynn, CR., Khan, MR., et al.[2023]

The Comprehensive Geriatric Assessment (CGA) program at Metro North Hospital identified health issues in older cancer patients, with 59% of the 1380 patients screened showing impairments that warranted further assessment.

The most common issues found through CGA included mobility problems, malnutrition, polypharmacy, and low mood, indicating that tailored interventions can significantly support older patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer - a highly accessible model of care. Thaker, DA., McGuire, P., Bryant, G., et al.[2021]

A comprehensive geriatric assessment (CGA) is increasingly recognized as a valuable tool for evaluating the overall health of elderly cancer patients, which can aid in treatment decisions and predict outcomes.

While CGA shows promise in oncology, there are practical challenges in its application that may affect its integration into standard clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comprehensive geriatric assessment in oncology: promises, pitfalls, and practicalities. Horgan, AM., Knox, JJ., Alibhai, SM.[2015]

In a study of 110 patients aged 70 and older undergoing Comprehensive Geriatric Assessment (CGA), 70% were found to have multiple health issues, highlighting the complexity of treating older cancer patients.

Despite the use of CGA and oncologist clinical judgment, neither method was effective in predicting unfavorable outcomes from cancer treatment, with a significant discrepancy noted between the two assessments in nearly 39% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting outcome in older patients with cancer: Comprehensive geriatric assessment and clinical judgment. Versteeg, KS., Looijaard, SMLM., Slee-Valentijn, MS., et al.[2021]

Comprehensive geriatric assessment (CGA) is a thorough evaluation that helps understand the overall health and needs of older cancer patients, considering factors like functional status, comorbidities, and social support.

Recent data indicates that CGA can effectively predict morbidity and mortality in older cancer patients, suggesting it could be beneficial in guiding interventions to enhance their cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oncogeriatrics: an attempt to operational definition]. De Breucker, S., Luce, S., Pepersack, T.[2009]

Citations

1.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2019.37.31_suppl.122

Comprehensive geriatric assessment in lung cancer and ...

Results: Median ages were 80 in lung cancer and 67 in hematologic malignancy. The lung cancer patients had a slower gait than patients with hematologic ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9993098/

The prognostic value of comprehensive geriatric ...

The median survival was 9.93 months (range, 1.53 to 36.30). Among CGA parameters, ADL and nutritional status had significant differences in OS in univariate ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11657378/

The value and effectiveness of geriatric assessments for ...

GAs seems to be beneficial for older adults with cancer across some outcomes, with strong evidence demonstrating the impact of GA with management for treatment ...

4.

thelancet.com

thelancet.com/journals/lanhl/article/PIIS2666-7568(25)00062-5/fulltext

Effectiveness of comprehensive geriatric assessment with ...

Recent randomised controlled trials (RCTs) in geriatric oncology have demonstrated that CGA improves clinical outcomes, including treatment ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666756822001696

Articles Integrated Geriatric Assessment and Treatment ...

Our findings suggest that CGA improved outcomes such as quality of life, unplanned hospital admissions, and chemotherapy completion in older ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7201727/

Impact of the comprehensive geriatric assessment on ...

The comprehensive geriatric assessment (CGA) is the gold standard in geriatric oncology to identify patients at high risk of adverse outcomes and optimize ...

7.

clinicaltrials.gov

clinicaltrials.gov/show/NCT05230888

Comprehensive Geriatric Assessment in Elderly Non-Small ...

A Prospective Study of Comprehensive Geriatric Assessment (CGA) in Non-Small Cell Lung Cancer Patients (NSCLC) Undergoing Treatment With Immune Checkpoint ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1879406822000820

Geriatric assessment in the management of older patients ...

The aim of this systematic review is to summarize all available data on the effect of a geriatric assessment in older patients with cancer, for oncologic ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11190321/

longitudinal geriatric assessment, treatment toxicity, and ...

We aimed to describe the feasibility of capturing functional disability and treatment toxicity among older adults with lung cancer using a longitudinal ...