100 Participants Needed

Geriatric Assessment for Cancer Care

ZF
LJ
Overseen ByLeslie J Fortin, MPH
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Fox Chase Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

Who Is on the Research Team?

ZF

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Sharing ArmExperimental Treatment1 Intervention
Group II: Delayed Sharing ArmActive Control1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

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

Citations

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 ...
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 ...
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 ...
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 ...
Geriatric Assessment of Older Patients with CancerThis paper focuses on recent data demonstrating the benefits of GA and GA-driven interventions on clinical outcomes of geriatric patients with ...
Application of comprehensive geriatric assessment in ...Application of comprehensive geriatric assessment in oncology nursing: A literature review on optimizing treatment decisions and patient outcomes
Geriatric Assessment: ASCO Global GuidelineThis clinical practice guideline addresses four overarching clinical questions posed in the 2023 Maximal-setting guideline update, with the ...
Comprehensive geriatric assessment for patients with cancerINTRODUCTION. Approximately 54 percent of new cases and 70 percent of mortality from cancer occur in patients ≥65 years of age [1,2].
Integrating Geriatric Assessment into Cancer Care - NCIRobust data now support geriatric assessment in the care delivery for older patients with cancer.
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 ...
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