Geriatric Assessment for Cancer

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

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.

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.

Is the Comprehensive Geriatric Assessment safe for older adults with cancer?

The Comprehensive Geriatric Assessment is generally considered safe for older adults with cancer, as it helps evaluate their overall health and treatment risks without involving any invasive procedures. ^{1 2 3 4 5}

How does the geriatric assessment treatment differ from other cancer treatments for older adults?

The geriatric assessment treatment is unique because it involves a comprehensive evaluation of an older adult's medical, psychological, social, and functional capacity, which helps tailor cancer treatment to their specific needs. This approach is different from standard treatments as it aims to improve decision-making and outcomes by considering the complex health issues often present in older patients. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Comprehensive Geriatric Assessment for older patients with cancer?

Research shows that a Comprehensive Geriatric Assessment (CGA) helps in predicting outcomes and making treatment decisions for older cancer patients. It evaluates various health aspects, which can guide interventions to improve cancer care quality and predict potential treatment complications. ^{3 9 10 11 12}

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 am about to start a new chemotherapy treatment.

I have been diagnosed with a solid tumor cancer.

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

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Predicting outcome in older patients with cancer: Comprehensive geriatric assessment and clinical judgment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The comprehensive geriatric assessment in oncology: promises, pitfalls, and practicalities. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

How to incorporate geriatric assessment in clinical decision-making for older patients with cancer. An implementation study. [2020]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Oncogeriatrics: an attempt to operational definition]. [2009]

6. France pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Should older patients with cancer visit a geriatrician as well? The value of geriatric assessments]. [2020]

9. United States 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. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Six independent domains are defined by geriatric assessment in elderly cancer patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Use of geriatric assessment for older adults in the oncology setting: a systematic review. [2022]

12. France pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. [2009]