Geriatric Assessment for Cancer Care

Overseen By Leslie J Fortin, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Incapacity to consent, Non-English speakers, Activity tracker users, others

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

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing older adults with detailed information about their health and physical abilities aids in making better cancer treatment choices. The study will determine if awareness of their health status alters their care priorities. Participants will receive this information either early or later in the process. It suits individuals aged 65 or older who have just begun or are about to begin a new cancer treatment plan. As an unphased trial, it offers participants the chance to contribute to research that could enhance decision-making in cancer care for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on assessing health and physical abilities rather than changing medications.

What prior data suggests that these assessments are safe for older adults?

Studies have shown that geriatric assessments are safe and beneficial for older adults with cancer. Research indicates that these assessments help doctors understand the health and abilities of older patients, guiding treatment choices and improving care. For example, a guideline from the American Society of Clinical Oncology supports using geriatric assessments to customize cancer care for older adults.

These assessments have been well-received in cancer care, with no reports of harm. They involve gathering information about a person's health and abilities through interviews and questionnaires, which are non-invasive and pose no physical risk to participants. Overall, evidence suggests that geriatric assessments are safe and useful for making informed medical decisions for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment for Cancer Care trial because it explores how sharing assessment results can impact cancer care for older adults. Unlike standard treatment approaches that may not tailor interventions based on comprehensive geriatric evaluations, this trial investigates both early and delayed sharing of these assessments with patients. The unique element here is the focus on how timing and awareness of functional and geriatric assessments can potentially enhance personalized care and decision-making, leading to better health outcomes for older cancer patients.

What evidence suggests that geriatric and objective functional assessments are effective for improving treatment decisions in older adults with cancer?

This trial will compare the effects of early versus delayed sharing of geriatric assessment (GA) and objective functional assessment (OFS) results with participants. Studies have shown that geriatric assessments can lead to better outcomes for older adults with cancer. Research indicates that these assessments enhance patient satisfaction and communication with healthcare providers. They provide a clearer picture of a patient's health, guiding more personalized and effective treatment decisions. Recent data suggest that GA-driven interventions may improve clinical outcomes, such as quality of life and understanding of treatment. Overall, evidence supports the value of GAs in helping older patients prioritize their treatment goals and make informed care decisions. ^{6 7 8 9 10}

Who Is on the Research Team?

Zachary A. Frosch

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for older adults considering cancer treatment. It's designed to see if detailed health and physical ability assessments help them make better-informed decisions about their care.

Inclusion Criteria

Started a new qualifying index regimen within the last 30 days (inclusive)

Being considered for a new qualifying index regimen

I am 65 years old or older.

Exclusion Criteria

Patients unable to complete English language questionnaires

Patients enrolled in another study where physical activity is a substantial part or all of the therapeutic intervention or specifically being evaluated and shared with patients

I am unable to understand or sign the study consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and undergo Geriatric Assessment (GA) and Objective Functional Status (OFS) assessments

1 week

1 visit (in-person)

Intervention

Participants in the intervention arm receive early sharing of GA and OFS results and complete the QQ Questionnaire again

4 weeks

1 visit (in-person), 1 visit (virtual)

Control

Participants in the control arm complete the QQ Questionnaire without receiving GA and OFS results initially

4 weeks

1 visit (in-person), 1 visit (virtual)

Follow-up

Participants complete the 'Was it Worth It' (WIWI) questionnaire and review their assessment results

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric and Objective Functional Assessments

Trial Overview

The study tests the impact of sharing geriatric and functional assessments with older patients on their treatment choices, aiming to align medical care with what they value most.

How Is the Trial Designed?

Group I: Early Sharing Arm Experimental Treatment 1 Intervention

early sharing of GA and OFS results to participants

Group II: Delayed Sharing Arm Active Control 1 Intervention

delayed sharing of GA and OFS results to participants

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

As the population ages, there is a growing need for effective tools to assess the functional and overall health status of older cancer patients, which can help oncologists tailor treatment plans more effectively.

Geriatric assessments have been shown to uncover previously unrecognized health issues in older patients, leading to targeted interventions that can improve treatment outcomes and patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaires and instruments for a multidimensional assessment of the older cancer patient: what clinicians need to know? Pallis, AG., Wedding, U., Lacombe, D., et al.[2022]

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]

In a pilot study involving 71 older adults (average age 76) with advanced solid tumors, a geriatric assessment (GA) identified impairments that could affect treatment outcomes, but the implementation of management recommendations was low (only 35.4% acted upon by oncologists).

Despite the GA management interventions, there was no significant difference in severe chemotherapy toxicity or other adverse outcomes (like hospitalizations and dose adjustments) between the intervention and usual care groups, suggesting that simply identifying impairments may not be enough to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management intervention in older adults with cancer: a randomized pilot study. Magnuson, A., Lemelman, T., Pandya, C., et al.[2019]

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]

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]

A self-administered questionnaire designed for older cancer patients (aged 65 and older) effectively identified various health needs, including physical and psychological impairments, nutritional issues, and lack of social support, in a study involving 245 participants.

The questionnaire was well-received, with high acceptance rates regarding its length and content, suggesting it is a feasible tool for integrating geriatric assessments into cancer care, although further trials are needed to evaluate the effectiveness of the resulting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. Hurria, A., Lichtman, SM., Gardes, J., et al.[2015]

Geriatric assessments can help predict certain outcomes in older cancer patients, such as all-cause mortality and chemotherapy toxicity, but the results are inconsistent across studies, making it difficult to use them reliably in treatment decisions.

A review of 51 studies found that different geriatric conditions, like frailty and cognitive impairment, were linked to various outcomes, but the overall quality of the studies was poor, highlighting the need for more research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of geriatric assessments in predicting treatment tolerance and all-cause mortality in older patients with cancer. Hamaker, ME., Vos, AG., Smorenburg, CH., et al.[2021]

A comprehensive geriatric assessment is increasingly important in managing cancer patients aged 70 and older, as it correlates with better understanding of their functional status and comorbidities.

Geriatric assessment tools are more effective than traditional oncological measures in evaluating functional status, and as patients age, their comorbidities significantly impact survival and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment with focus on instrument selectivity for outcomes. Extermann, M.[2019]

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 301 older cancer patients receiving radiotherapy, a significant number had geriatric impairments, with 26.9% experiencing four or more impairments, which correlated with decreased overall survival rates.

Nutritional status and the ability to perform daily activities (IADL) were identified as independent predictors of overall survival, suggesting that addressing these factors could potentially improve outcomes for older patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric impairments are prevalent and predictive of survival in older patients with cancer receiving radiotherapy: a prospective observational study. Eriksen, GF., Šaltytė Benth, J., Grønberg, BH., et al.[2022]

A new geriatric assessment for older cancer patients aims to evaluate 'functional age' rather than just chronological age, helping oncologists tailor treatment and improve outcomes for this population.

The assessment is designed to be valid, reliable, and easy to self-administer, focusing on key factors that predict survival and treatment risks, ultimately seeking to enhance cancer care for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment for oncologists: rationale and future directions. Hurria, A., Lachs, MS., Cohen, HJ., et al.[2010]

Chronological age alone is not a reliable indicator for making treatment decisions in older cancer patients, as it does not reflect their true physiological and functional status.

A comprehensive geriatric assessment can provide valuable insights into various aspects of an older patient's health, helping oncologists make more informed, personalized treatment decisions that consider the patient's overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional versus chronological age: geriatric assessments to guide decision making in older patients with cancer. Soto-Perez-de-Celis, E., Li, D., Yuan, Y., et al.[2019]

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]

Up to 64% of elderly cancer patients experience severe toxicity from chemotherapy, highlighting the need for better predictive tools to guide treatment and minimize risks.

Geriatric Assessment (GA) can uncover previously unknown health issues in over 50% of older patients, and 21%-53% of chemotherapy regimens are adjusted based on GA findings, suggesting its potential value in optimizing treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of treatment-related toxicity and outcome with geriatric assessment in elderly patients with solid malignancies treated with chemotherapy: a systematic review. Versteeg, KS., Konings, IR., Lagaay, AM., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10472678/

Geriatric assessment for older people with cancer: policy ...

An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In ...

2.

bmcgeriatr.biomedcentral.com

bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05607-9

The value and effectiveness of geriatric assessments for older ...

This umbrella review aimed to summarise and synthesize the evidence on the outcomes reported and used to assess the value and or efficacy of ...

3.

thelancet.com

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

Effectiveness of comprehensive geriatric assessment with ...

Recently published randomised controlled trials (RCTs) have shown that implementing CGA improves outcomes for older patients with cancer. It ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1879406825001638

Geriatric assessment in older adults with cancer: A global ...

Furthermore, the use of GA in cancer care of older adults has been associated with increased patient and caregiver satisfaction and improved communication ...

5.

onco-hema.healthbooktimes.org

onco-hema.healthbooktimes.org/article/94081-geriatric-assessment-of-older-patients-with-cancer-recent-data-and-updated-recommendations

Geriatric Assessment of Older Patients with Cancer

This paper focuses on recent data demonstrating the benefits of GA and GA-driven interventions on clinical outcomes of geriatric patients with ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12019282/

Application of comprehensive geriatric assessment in ...

Application of comprehensive geriatric assessment in oncology nursing: A literature review on optimizing treatment decisions and patient outcomes

7.

ascopubs.org

ascopubs.org/doi/10.1200/GO-25-00276

Geriatric Assessment: ASCO Global Guideline

This clinical practice guideline addresses four overarching clinical questions posed in the 2023 Maximal-setting guideline update, with the ...

8.

uptodate.com

uptodate.com/contents/comprehensive-geriatric-assessment-for-patients-with-cancer

Comprehensive geriatric assessment for patients with cancer

INTRODUCTION. Approximately 54 percent of new cases and 70 percent of mortality from cancer occur in patients ≥65 years of age [1,2].

9.

cancer.gov

cancer.gov/news-events/cancer-currents-blog/2018/geriatric-assessment-cancer-care-mohile

Integrating Geriatric Assessment into Cancer Care - NCI

Robust data now support geriatric assessment in the care delivery for older patients with cancer.

10.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1879406823001820

The effect of comprehensive geriatric assessment on care ...

This systematic review seeks to evaluate the impact of a 'GA with intervention' or CGA (GA/CGA) on outcomes for older adults with cancer receiving systemic ...