Assessment Tool for Cancer Care Planning

Not currently recruiting at 7 trial locations

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must be taking: Chemotherapy

Disqualifiers: Non-English speakers, Phase I trial, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a tool that helps doctors assess how older cancer patients think, learn, remember, and manage daily tasks. The goal is to improve treatment planning for these patients. It focuses on individuals with confirmed cancer who are about to begin a new chemotherapy regimen. Participants must understand English and not have participated in this specific trial before. This assessment could lead to better-tailored care for older adults undergoing cancer treatment. As an unphased trial, this study offers participants the chance to contribute to research that could enhance personalized care for older cancer patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this assessment tool is safe for older patients with cancer?

Research shows that tools like the one in this trial help doctors understand the needs of older cancer patients. These tools assess patients' cognitive abilities and daily functioning. Studies have found these assessments to be safe and non-invasive. They assist doctors in predicting patients' responses to treatments and potential side effects, such as severe reactions or hospitalizations. Since the tool is neither a drug nor a physical treatment, no major risks or negative effects have been reported from its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment Tool because it offers a personalized approach to cancer care for older patients. Unlike traditional treatment plans that often overlook the specific needs of older adults, this tool focuses on assessing a patient’s overall health, functionality, and social support. This comprehensive evaluation helps tailor cancer treatments to better suit each individual, potentially leading to improved outcomes and quality of life. By addressing factors beyond the cancer itself, this tool has the potential to transform how care is planned for older cancer patients.

What evidence suggests that this assessment tool is effective for cancer care planning in older patients?

Research shows that the geriatric assessment tool, studied in this trial, is the best method for evaluating how well older cancer patients can handle treatment. Studies have found that this tool helps predict patient reactions to chemotherapy, including the risk of severe side effects. It also enhances communication and satisfaction for both patients and caregivers. Additionally, using this tool to guide treatment decisions has been linked to better health outcomes. Overall, the geriatric assessment tool proves very useful in managing care for older adults with cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Dale William, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with any type of cancer who are about to start a new chemotherapy regimen. They must have confirmed cancer, understand English, and not be enrolled in another phase I clinical trial or this trial previously.

Inclusion Criteria

Pathologically confirmed cancer

Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen

Must be able to understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Patients undergo assessments of functional status, cognition, and complete self-administered questionnaires

1-2 weeks

Treatment

Patients begin planned chemotherapy

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments and questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Assessment Tool for Older Patients With Cancer

Trial Overview The study is testing an assessment tool designed to evaluate cognitive functions and daily activity abilities in older cancer patients. This includes understanding how they think, learn, remember, make judgments during their treatment process.

How Is the Trial Designed?

Group I: Geriatric Assessment Tool Experimental Treatment 3 Interventions

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 136 older cancer patients (average age 77), over half were exposed to potentially inappropriate medications (PIMs) and one-third had relevant potential drug-drug interactions (rPDDIs), which increased after starting cancer therapy.

The presence of rPDDIs was significantly associated with severe overall toxicity and specifically with hematological toxicity during treatment, indicating a need for careful medication management in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication risks in older patients (70 +) with cancer and their association with therapy-related toxicity. Ortland, I., Mendel Ott, M., Kowar, M., et al.[2022]

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 (GA) intervention significantly reduced the incidence of moderate to severe symptomatic toxicity in older patients (age ≥ 70) with advanced cancer, as shown in a study of 706 patients.

Patients receiving the GA intervention reported fewer grade ≥ 2 symptoms compared to those receiving usual care (88.9% vs 94.8%), indicating that tailored management recommendations can improve patient experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. Culakova, E., Mohile, SG., Peppone, L., et al.[2023]

A new comprehensive geriatric assessment tool was developed specifically for older patients with advanced cancer, addressing various medical, psychosocial, and functional issues, which is crucial given that 60% of elderly patients may have cancer.

The tool incorporates validated measures across multiple domains, ensuring it is brief, reliable, and valid for use in palliative care settings, with plans for further testing and implementation in a comprehensive geriatric palliative care project.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a comprehensive cancer specific geriatric assessment tool. Rao, S., Salins, N., Deodhar, J., et al.[2016]

As the population ages, there will be an increasing number of older cancer patients, necessitating careful selection of treatment plans based on individual health and resources.

Utilizing comprehensive geriatric assessments can help identify which older patients will benefit from aggressive cancer treatments versus palliative care, ultimately improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to the older patient with cancer. de la Cruz, M., Bruera, E.[2021]

A systematic review of 9 studies involving older adults (aged ≥65 years) found that eHealth tools for receiving health test results generally improved satisfaction and quality of life, indicating their potential benefit in cancer treatment decision-making.

Challenges such as poorly designed user interfaces and older adults' lack of confidence in using eHealth tools hindered their uptake, highlighting the need for more intuitive designs tailored to this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Medical Information to Older Adults in a Web-Based Environment: Systematic Review. McLean, B., Hossain, N., Donison, V., et al.[2021]

A systematic review of 725 publications identified at least 528 different outcome assessment instruments used in palliative care, highlighting the lack of consensus on standardized tools for measuring outcomes.

The study found that while many instruments exist across various domains (like quality of life and symptom management), most are not validated, suggesting a need for a unified framework to improve comparability and identify gaps in assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome assessment instruments in palliative and hospice care--a review of the literature. Stiel, S., Pastrana, T., Balzer, C., et al.[2021]

Citations

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

Geriatric assessment for older people with cancer: policy ... In older patients, the geriatric assessment (GA) is the gold standard to measure level of fitness and to determine treatment tolerability.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00477958

Assessment Tool for Older Patients With Cancer Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, ...

3. 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 ...

4. onco-hema.healthbooktimes.org onco-hema.healthbooktimes.org/article/94081

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 cancer.

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

The value and effectiveness of geriatric assessments for older ... GAs seems to be beneficial for older adults with cancer across some outcomes, with strong evidence demonstrating the impact of GA with management for treatment ...

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

Geriatric Assessment: ASCO Global Guideline A geriatric evaluation should at a minimum include the use of a brief geriatric screening tool. Tools in the Practical Geriatric Assessment (PGA) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12204759/

The prognostic role of Geriatric 8 in patients with cancer Decreased G-8 scores are significantly associated with poor survival in patients with cancer. G-8 is a promising tool for frailty screening.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1879406822000820

Geriatric assessment in the management of older patients ... The aim of this systematic review is to summarize all available data on the effect of a geriatric assessment in older patients with cancer, for oncologic ...