Aging Assessment Tool for Cancer Patients
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
No Placebo Group
Trial Summary
What is the purpose of this trial?Aging is the greatest risk factor for cancer incidence and mortality. Geriatric screening is recommended to help with treatment discussions, inform intensity of treatment, and identify supportive care needs. Despite a strong evidence base, geriatric assessments are not implemented routinely in oncologic clinics. Similarly, important information on social determinants of health, mental health, and health behaviors are inconsistently assessed, and almost never in an integrated fashion. In an effort to support clinicians delivering the recommended goal-concordant care, the investigators will integrate assessment of geriatric issues, health behaviors, mental health, and social determinants of health into an efficient, actionable contextual assessment system for older cancer patients called Integrated Aging Assessment for Action for Cancer Patients (IA3-CP). The investigators will use D\&I strategies including co-creation engagement approaches and form-function methods to develop workflow processes that feasibly integrate the IA3-CP into usual initial assessment with the oncology team. Our objective is to develop and conduct a randomized pilot of the IA3-CP system and hypothesize that our results will show it can be implemented consistently, acted on, improve quality of care, and enhance patient-provider interactions.
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for the Aging Assessment Tool for Cancer Patients?The provided research does not directly mention safety data for the Aging Assessment Tool for Cancer Patients or its alternative name, IA3-CP. However, it highlights the importance of geriatric assessments in identifying risks of treatment-related toxicities in older cancer patients. These studies suggest that tools incorporating geriatric assessments can help predict and manage chemotherapy-related toxicity, which is crucial for ensuring the safety of older patients in cancer treatment.79111314
What data supports the idea that Aging Assessment Tool for Cancer Patients (also known as: Integrated Aging Assessment for Action for Cancer Patients (IA3-CP)) is an effective treatment?The available research shows that the Aging Assessment Tool for Cancer Patients helps doctors understand the 'functional age' of older cancer patients, which is more important than just knowing their actual age. This tool helps tailor cancer treatments to each patient's needs, improving their quality of life and independence. It is also easy for patients to use on their own, which makes it practical in real-world settings. Compared to other methods, this tool focuses on what matters most to older patients, like their ability to live independently and their overall well-being, rather than just survival rates.124511
Is the treatment Integrated Aging Assessment for Action for Cancer Patients (IA3-CP) a promising treatment for older cancer patients?Yes, the Integrated Aging Assessment for Action for Cancer Patients (IA3-CP) is a promising treatment. It helps doctors understand the unique needs of older cancer patients by looking at their overall health, not just their age. This approach can lead to better, more personalized care, improving the quality of life and treatment outcomes for older adults with cancer.3681012
Eligibility Criteria
This trial is for cancer patients aged 65 or older who speak English or Spanish and are attending their initial oncology visit. They must be willing to participate in all study activities. It's open to those with various cancers, including leukemia, multiple myeloma, kidney tumors, breast cancer, Hodgkin's lymphoma, prostate cancer, and bladder cancer.Inclusion Criteria
I am 65 years old or older.
I am 65 years old or older.
Exclusion Criteria
I am under 65 years old.
My primary language is neither English nor Spanish.
Participant Groups
The trial tests an assessment tool called IA3-CP designed to integrate geriatric issues, health behaviors, mental health assessments along with social determinants of health (SDoH). Patients will either receive the IA3-CP with SDoH considerations or without them to see how well these tools can be implemented and improve care.
3Treatment groups
Experimental Treatment
Active Control
Group I: IA3-CP with SDoHExperimental Treatment1 Intervention
Assess IA3-CP with SDoH and provide feedback (provider \& patient)
Group II: IA3-CP onlyExperimental Treatment1 Intervention
Assess IA3-CP only without added SDoH and provide feedback (provider \& patient)
Group III: Control - usual careActive Control1 Intervention
Usual care: Assess IA3-CP without providing the feedback report
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Colorado HospitalAurora, CO
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Developing a cancer-specific geriatric assessment: a feasibility study. [2010]As the U.S. population ages, there is an emerging need to characterize the "functional age" of older patients with cancer to tailor treatment decisions and stratify outcomes based on factors other than chronologic age. The goals of the current study were to develop a brief, but comprehensive, primarily self-administered cancer-specific geriatric assessment measure and to determine its feasibility as measured by 1) the percentage of patients able to complete the measure on their own, 2) the length of time to complete, and 3) patient satisfaction with the measure.
Geriatric assessment for oncologists: rationale and future directions. [2010]Sixty percent of all cancer occurrences and seventy percent of cancer mortalities occur in people over the age of 65. As the population ages, there is an emerging need to develop a means for oncologists to characterize the "functional age" of older patients with cancer in order to tailor treatment decisions and stratify outcomes based on factors other than chronological age and to develop interventions to optimize cancer treatment. In this paper, we discuss the formulation of a geriatric assessment for older patients with cancer. The measures included in this assessment were chosen based on their validity, reliability, brevity, adaptability for self-administration, and ability to prognosticate risk for morbidity or mortality in an older patient. The proposed geriatric assessment covers the essential domains of assessment predictive of survival in the geriatric population, is primarily self-administered, and limited personnel time is required. Our eventual goal is to determine if this geriatric assessment measure can identify factors independent of age that predict cancer treatment morbidity and mortality and result in rationale interventions to optimize oncologic care.
Geriatric assessment in oncology practice. [2021]There is no standard tool for assessing the "functional age" of an older adult with cancer, although it is widely recognized that chronological age does not capture the heterogeneous physiological and functional status of older adults. Integrating a "geriatric assessment" into oncology research and clinical practice would help fill this void. Geriatric assessment covers factors that predict morbidity and mortality in older adults, including functional status, comorbidity, cognition, psychological state, nutritional status, and social support. This assessment provides a broader overall understanding of individual characteristics that affect life expectancy. In addition, this assessment identifies areas of vulnerability in older adults for which further evaluation or intervention is indicated. This article will address the utility of a geriatric assessment in oncology practice, review data that attest to the benefits of the assessment, and issue a call for further research into how this assessment can be integrated into oncology care. Doing so will help develop targeted interventions and optimize cancer outcomes in this rapidly growing population.
Evaluating the older patient with cancer: understanding frailty and the geriatric assessment. [2022]The majority of cancer incidence and mortality occurs in individuals aged older than 65 years, and the number of older adults with cancer is projected to significantly increase secondary to the aging of the US population. As such, understanding the changes accompanying age in the context of the cancer patient is of critical importance. Age-related changes can impact tolerance of anticancer therapy and can shift the overall risk-benefit ratio of such treatment. A challenge in implementing evidence-based approaches in older adults is the under-representation of this group in oncology clinical trials. In addition, although older adults are particularly vulnerable to the side effects of cancer therapy, few oncology studies to date have incorporated a measure of health status other than the Eastern Cooperative Oncology Group or Karnofsky performance scales. Novel metrics such as frailty indices or the geriatric assessment recognize heterogeneity among older adults, and may allow for risk-adapted approaches to therapy. It is increasingly recognized that several laboratory markers may predict morbidity and mortality in older adults; these biologic variables may further aid in stratifying this group of patients based on risk. This review describes key studies from the geriatric literature that provide principles for assessing health status in the older patient, and ways that these principles can be applied to oncology care in an older population are proposed.
Analysis of prognostic factors of comprehensive geriatric assessment and development of a clinical scoring system in elderly Asian patients with cancer. [2022]To determine the impact of each comprehensive geriatric assessment (CGA) domain on overall survival (OS) and develop a prognostic scoring system for elderly patients with cancer.
Developing a comprehensive cancer specific geriatric assessment tool. [2016]Population aging is one of the most distinctive demographic events of this century. United Nations projections suggest that the number of older persons is expected to increase by more than double from 841 million in 2013 to >2 billion by 2050. It is estimated that 60% of the elderly patients may be affected by cancer and may present in the advanced stage. The aim of this paper was to develop a brief cancer-specific comprehensive geriatric assessment tool for use in a geriatric population with advanced cancer that would identify the various medical, psychosocial, and functional issues in the older person.
Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. [2022]Older adults are at increased risk for chemotherapy toxicity, and standard oncology assessment measures cannot identify those at risk. A predictive model for chemotherapy toxicity was developed (N = 500) that consisted of geriatric assessment questions and other clinical variables. This study aims to externally validate this model in an independent cohort (N = 250).
Management of Cancer in the Older Age Person: An Approach to Complex Medical Decisions. [2018]The management of cancer in older aged people is becoming a common problem due to the aging of the population. There are many variables determining the complex situation that are interconnected. Some of them can be assessed, such as risk of mortality and risk of treatment complications, but many others are still unknown, such as the course of disease, the host-related factors that influence cancer aggressiveness, and the phenotype heralding risk of permanent treatment-related damage.This article presents a dynamic and personalized approach to older people with cancer based on our experience on aging, cancer, and their biological interactions. Also, novel treatments and management approaches to older individuals, based on their functional age and their social and emotional needs, are thoughtfully explored here. The Oncologist 2017;22:335-342 IMPLICATIONS FOR PRACTICE: The goal of this article is to suggest a practical approach to complexity, a clinical situation becoming increasingly common with the aging of the population. Beginning with the analysis of two clinical cases, the authors offer an algorithm for approaching cancer in the older person that involves the assessment of life expectancy without cancer, the risk that cancer might compromise a patient's survival, function, or quality of life, and the potential benefits and risks of the treatments based on a clinical evaluation. The authors then review possible laboratory assessment of functional age and the importance of rapid-learning databases in the study of cancer and age.
Risk Factors for Chemotherapy-Related Toxicity and Adverse Events in Elderly Thai Cancer Patients: A Prospective Study. [2018]To assess factors predisposing to severe chemotherapy-related toxicity and adverse events (AEs) and dose modification in aging cancer patients.
Functional versus chronological age: geriatric assessments to guide decision making in older patients with cancer. [2019]As the worldwide population ages, oncologists are often required to make difficult and complex decisions regarding the treatment of older people (aged 65 years and older) with cancer. Chronological age alone is often a poor indicator of the physiological and functional status of older adults, and thus should not be the main factor guiding treatment decisions in oncology. By contrast, a geriatric assessment can provide a much more comprehensive understanding of the functional and physiological age of an older person with cancer. The geriatric assessment is a multidimensional tool that evaluates several domains, including physical function, cognition, nutrition, comorbidities, psychological status, and social support. In this Series paper, we discuss the use of a geriatric assessment-based approach to cancer care, and provide clinicians with tools to better assess the risks and benefits of treatment to engage in shared decision making and provide better personalised care for older people with cancer.
Optimising Clinical Trial Design in Older Cancer Patients. [2020]Cancer is predominantly a disease of older patients, with over half of those aged over 65 years of age being diagnosed with cancer at some stage. Despite comprising a significant proportion of the patients that we see in clinical practice, there is a lack of representation of older patients in cancer clinical trials. This is mainly due to restrictive trial inclusion criteria that prevent older patients from participating. Also, trial endpoints, such as overall survival, may not represent the most important and most meaningful endpoints for older patients. The latter may place more significance on quality of life and other outcomes such as functional independence. Baseline assessment using Comprehensive Geriatric Assessment, may provide a better framework for quantifying patient outcomes for varying degrees of fitness or frailty. This short communication makes the case for more age appropriate endpoints, such as quality of life, toxicity and functional independence, and that novel trial designs are necessary to inform evidence-based care of older cancer patients.
Applying a Life Course Biological Age Framework to Improving the Care of Individuals With Adult Cancers: Review and Research Recommendations. [2023]The practice of oncology will increasingly involve the care of a growing population of individuals with midlife and late-life cancers. Managing cancer in these individuals is complex, based on differences in biological age at diagnosis. Biological age is a measure of accumulated life course damage to biological systems, loss of reserve, and vulnerability to functional deterioration and death. Biological age is important because it affects the ability to manage the rigors of cancer therapy, survivors' function, and cancer progression. However, biological age is not always clinically apparent. This review presents a conceptual framework of life course biological aging, summarizes candidate measures, and describes a research agenda to facilitate clinical translation to oncology practice.
Medication risks in older patients (70 +) with cancer and their association with therapy-related toxicity. [2022]To evaluate medication-related risks in older patients with cancer and their association with severe toxicity during antineoplastic therapy.
Patient-reported geriatric assessment-based frailty index among older adults with gastrointestinal malignancies. [2023]Older adults with cancer are at increased risk of treatment-related toxicities and excess mortality. We evaluated whether a patient-reported geriatric assessment (GA) based frailty index can identify those at risk of adverse outcomes.