Geriatric Assessment for Cancer

Not currently recruiting at 4 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Non-English, Spanish, Chinese speakers

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a detailed health check-up (geriatric assessment) can predict how older adults with cancer will respond to chemotherapy and identify any weaknesses. Participants will either follow a treatment plan based on this assessment or receive standard cancer care. The goal is to improve care by identifying vulnerabilities, potentially reducing chemotherapy side effects. This trial targets older adults with any stage of solid tumor cancer who are about to begin new chemotherapy treatments and can communicate in English, Spanish, or Chinese. As an unphased trial, it offers a unique opportunity for patients to contribute to research that could enhance personalized cancer care.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Comprehensive Geriatric Assessment is safe for older patients with cancer?

Research has shown that comprehensive geriatric assessments are safe and well-tolerated by older adults with cancer. These assessments help predict and manage chemotherapy side effects by evaluating a patient's physical health, mental state, and social support.

In one study, patients who underwent a geriatric assessment experienced fewer severe side effects from chemotherapy, meaning they had fewer serious reactions to treatment. The assessment often led to better care plans, including adjustments to treatments that fit a person's specific health needs.

These findings are encouraging, suggesting that comprehensive geriatric assessments do not cause harm and effectively improve cancer care in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the geriatric assessment-driven treatment for cancer because it tailors the care plan specifically to the needs of older patients. Unlike standard treatments that rely on a one-size-fits-all approach, this method uses a comprehensive evaluation to identify a patient’s unique vulnerabilities and strengths. This personalized assessment allows healthcare providers to create a more effective and targeted intervention plan, potentially improving the patient's quality of life. Additionally, the use of telehealth for delivering these plans makes it more accessible, especially for those who might have difficulty traveling to appointments.

What evidence suggests that the geriatric assessment intervention is effective for predicting chemotherapy toxicity in older cancer patients?

This trial will compare geriatric assessment-driven treatment with standard care for older cancer patients. Research has shown that thorough check-ups for older cancer patients can lead to better outcomes. Recent studies have found that these assessments help create personalized treatment plans by identifying issues like memory problems, poor nutrition, and low physical activity. This information can then adjust cancer care, potentially reducing treatment complications. Although some studies find the overall health benefits unclear, using these check-ups in cancer care has shown promise in improving treatment choices and patient care. ^{6 7 8 9 10}

Who Is on the Research Team?

Daneng Li

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with any stage of solid tumor cancer who are about to start a new chemotherapy regimen. Participants must speak English, Spanish, or Chinese and be able to give written consent. It's not open to those who aren't fluent in these languages.

Inclusion Criteria

I have been diagnosed with a solid tumor cancer.

I am about to start a new chemotherapy treatment.

Able to provide written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Assessment

Participants undergo a geriatric assessment to identify vulnerabilities and potential referrals

1-2 weeks

1 visit (in-person or via Telehealth)

Treatment

Participants receive chemotherapy with interventions based on geriatric assessment results

6 months

Regular visits (in-person or via Telehealth)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Geriatric Assessment

Trial Overview

The study tests if assessing an older patient's overall health before chemotherapy can predict treatment side effects and identify vulnerabilities. Patients will complete questionnaires and undergo comprehensive assessments covering function, comorbidities, psychology, social support, nutrition, and cognition.

How Is the Trial Designed?

Group I: Arm I (geriatric assessment-driven treatment) Experimental Treatment 4 Interventions

Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.

Group II: Arm II (standard of care) Active Control 3 Interventions

Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.

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

Collaboration between oncologists and geriatricians is crucial for assessing risks in elderly cancer patients, focusing on vulnerability, potential death, and severe side effects from chemotherapy.

Utilizing comprehensive geriatric assessments and predictive scores allows for a thorough evaluation of elderly patients, helping to inform treatment decisions in a multidimensional way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. Pamoukdjian, F., Ferreira, A.[2019]

In a study of 292 cancer patients aged 65 and older, a high prevalence of geriatric conditions was found, including instrumental ADL impairment (78%) and depressive symptoms (65%), indicating significant health challenges in this population.

Mortality rates were notably high, with 38% of patients dying within 3 months and 64% within 12 months, but mortality was primarily linked to cancer-related factors rather than geriatric conditions, suggesting that cancer severity may be a more critical determinant of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. Hamaker, ME., Buurman, BM., van Munster, BC., et al.[2021]

Geriatric assessment in oncology is feasible and typically takes 10-45 minutes, with certain assessment domains linked to treatment toxicity and mortality in older cancer patients.

While some studies suggest that geriatric assessment can influence treatment decisions in 40%-50% of cases, overall evidence on its impact on decision-making and outcomes remains limited, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of geriatric assessment for older adults in the oncology setting: a systematic review. Puts, MT., Hardt, J., Monette, J., et al.[2022]

Geriatric oncology focuses on the specialized management of older cancer patients, utilizing comprehensive geriatric assessments to address their complex medical needs.

Current research aims to identify key geriatric variables for clinical trials and develop screening tools to assess frailty in older cancer patients, ultimately improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. Terret, C., Gaujard, S., Droz, JP.[2009]

In a study involving 197 older patients with solid tumors, implementing a nurse-led geriatric assessment (GA) and patient preference evaluation led to treatment recommendations differing from the tumor board's suggestions in 27% of cases, often favoring less intensive treatment options.

The onco-geriatric multidisciplinary team (MDT) approach not only adjusted treatment plans for many patients but also resulted in 13% of patients being referred to a geriatrician for further evaluation, highlighting the importance of tailored care in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. Festen, S., Kok, M., Hopstaken, JS., et al.[2020]

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]

A geriatric assessment (GA) tool can be effectively implemented in community oncology clinics, with 339 out of 1088 patients assessed in these settings, demonstrating its feasibility for older adults receiving cancer treatment.

The time taken to complete the GA was comparable between academic and community clinics, suggesting that this assessment can be integrated into routine care without significant delays, although more patients in community settings required assistance with the questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. Williams, GR., Deal, AM., Jolly, TA., et al.[2016]

A geriatric assessment is crucial for older cancer patients as it evaluates their medical, psychosocial, and functional health, helping to identify vulnerabilities and predict treatment outcomes.

Despite its benefits in guiding treatment decisions and interventions, the use of geriatric assessments in oncology is limited by time constraints, resource availability, and the need for expert interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Every Oncologist Should Know About Geriatric Assessment for Older Patients With Cancer: Young International Society of Geriatric Oncology Position Paper. Loh, KP., Soto-Perez-de-Celis, E., Hsu, T., et al.[2022]

A study involving 78 elderly cancer patients identified six key domains of geriatric assessment: general functioning, health-related quality of life, co-morbidities, social support, cognition, and nutritional status, explaining 77.1% of the variance in patient assessments.

Traditional assessment tools like WHO Performance Status and Karnofsky Index are effective for measuring physical functioning but do not adequately address other critical areas such as cognitive functioning and social support, highlighting the need for a more comprehensive approach in geriatric assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six independent domains are defined by geriatric assessment in elderly cancer patients. Stauder, R., Moser, K., Holzner, B., et al.[2019]

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]

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]

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