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

Trial Summary

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 data supports the effectiveness of the treatment Geriatric and Objective Functional Assessments for cancer care?

Research shows that using geriatric assessments in cancer care helps identify problems that might not be obvious, allowing doctors to adjust treatments and improve outcomes for older patients. These assessments are more sensitive than traditional methods in evaluating a patient's ability to handle cancer treatments, which can lead to better treatment plans and potentially improve survival rates. ^{1 2 3 4 5}

Is the Geriatric Assessment for Cancer Care safe for humans?

Geriatric Assessment (GA) is generally safe and helps identify health issues in older adults with cancer, which can improve treatment decisions and outcomes. It is used to predict potential treatment-related risks and manage them effectively, ensuring better care for elderly patients. ^{6 7 8 9 10}

How is the Geriatric and Objective Functional Assessments treatment different from other cancer treatments for older adults?

This treatment is unique because it uses a comprehensive geriatric assessment to evaluate the overall health and functional status of older cancer patients, rather than just their age. This approach helps tailor cancer care to the individual's specific needs, potentially improving treatment decisions and outcomes. ^{10 11 12 13 14}

What is the purpose of this trial?

This Interventional clinical study aims to explore how receiving information about their health and physical abilities affects the treatment decisions of older adults. The study will look at whether sharing detailed assessments of their health and functional status helps older adults better understand their condition and make informed decisions about their care. The main question it aims to answer is if providing this information changes the treatment priorities of older adults, helping them focus on what matters most to them in their medical care.

Research Team

Zachary A. Frosch

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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

I am 65 years old or older.

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

Being considered for a new qualifying index regimen

Exclusion Criteria

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

Patients unable to complete English language questionnaires

Patients already using an activity tracker on a daily basis

Timeline

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

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]

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 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]

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]

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 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]

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]

References

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

Questionnaires and instruments for a multidimensional assessment of the older cancer patient: what clinicians need to know? [2022]

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

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. [2015]

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

The value of geriatric assessments in predicting treatment tolerance and all-cause mortality in older patients with cancer. [2021]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Geriatric assessment for oncologists: rationale and future directions. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Geriatric impairments are prevalent and predictive of survival in older patients with cancer receiving radiotherapy: a prospective observational study. [2022]

7. France pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management intervention in older adults with cancer: a randomized pilot study. [2019]

9. England 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. [2023]

10. 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]

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

[Current views in geriatric oncology]. [2009]

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

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

14. England pubmed.ncbi.nlm.nih.gov

Functional versus chronological age: geriatric assessments to guide decision making in older patients with cancer. [2019]