Aging Assessment Tool for Cancer Patients

Overseen By Bryan Ford

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Age < 65, Non-English/Spanish

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

35 Participants Needed

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Integrated Aging Assessment for Action for Cancer Patients (IA3-CP)?

The research highlights the importance of using geriatric assessments to better understand the health status of older cancer patients, which can help tailor treatments to improve outcomes like quality of life and functional independence. These assessments can identify factors beyond age that affect treatment success, suggesting that IA3-CP could be effective in optimizing cancer care for older adults. ^{1 2 3 4 5}

Is the Aging Assessment Tool for Cancer Patients safe for humans?

The research highlights that older adults with cancer are at increased risk of treatment-related toxicities, but it does not provide specific safety data for the Aging Assessment Tool for Cancer Patients. It suggests that comprehensive assessments may help identify those at risk of adverse outcomes, but no direct safety information for the tool itself is available. ^{2 6 7 8 9}

How is the IA3-CP treatment different from other treatments for cancer in older patients?

The IA3-CP treatment is unique because it uses a comprehensive geriatric assessment to tailor cancer care specifically for older patients, considering their functional age rather than just their chronological age. This approach helps identify medical, psychosocial, and functional issues, allowing for more personalized and effective treatment plans. ^{10 11 12 13 14}

Research Team

Russell E Glasgow

Principal Investigator

University of Colorado, Denver

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.

Patient must agree to participate in all study-related activities

Exclusion Criteria

I am under 65 years old.

My primary language is neither English nor Spanish.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Integration of geriatric issues, health behaviors, mental health, and social determinants of health into the IA3-CP system

12 weeks

Multiple visits (in-person and virtual)

Treatment

Participants receive feedback and care planning based on IA3-CP assessments

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Treatment Details

Interventions

• Integrated Aging Assessment for Action for Cancer Patients (IA3-CP)

Trial Overview 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.

Participant Groups

Group I: IA3-CP with SDoH Experimental Treatment 1 Intervention

Assess IA3-CP with SDoH and provide feedback (provider \& patient)

Group II: IA3-CP only Experimental Treatment 1 Intervention

Assess IA3-CP only without added SDoH and provide feedback (provider \& patient)

Group III: Control - usual care Active Control 1 Intervention

Usual care: Assess IA3-CP without providing the feedback report

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A new self-administered geriatric assessment measure for older cancer patients was developed and successfully completed by 78% of participants without assistance, indicating its feasibility for use in clinical settings.

The assessment took an average of 27 minutes to complete, and 90% of patients reported satisfaction with its length, suggesting it is both efficient and well-received by older patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific geriatric assessment: a feasibility study. Hurria, A., Gupta, S., Zauderer, M., et al.[2010]

Older patients, who make up a significant portion of cancer diagnoses, are often underrepresented in clinical trials due to restrictive inclusion criteria, which limits their access to potentially beneficial treatments.

There is a need for clinical trials to focus on age-appropriate endpoints, such as quality of life and functional independence, rather than just overall survival, to better address the specific needs and priorities of older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising Clinical Trial Design in Older Cancer Patients. Whelehan, S., Lynch, O., Treacy, N., et al.[2020]

Older adults (over 65 years) represent a significant portion of cancer cases and deaths, highlighting the need for tailored cancer treatments that consider age-related changes in health and therapy tolerance.

Current oncology trials often under-represent older adults and typically use limited health status measures; incorporating comprehensive assessments like frailty indices could improve treatment strategies and outcomes for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the older patient with cancer: understanding frailty and the geriatric assessment. Pal, SK., Katheria, V., Hurria, A.[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]

A comprehensive geriatric assessment (CGA) of 249 elderly cancer patients revealed that factors such as age, abnormal albumin levels, poor performance status, depression, malnutrition risk, and advanced disease stage are significant independent predictors of overall survival.

The study developed a nomogram based on these factors, which can help predict survival outcomes for elderly cancer patients, emphasizing the importance of CGA in tailoring interventions for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of prognostic factors of comprehensive geriatric assessment and development of a clinical scoring system in elderly Asian patients with cancer. Kanesvaran, R., Li, H., Koo, KN., et al.[2022]

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]

In a study of 151 cancer patients aged 70 and older, those with a poorer performance status (PS 2) experienced significantly higher rates of severe chemotherapy-related adverse events (71% vs. 39%) and had a worse quality of life after treatment.

More than half of the patients (51.6%) required modifications to their chemotherapy regimen due to toxicities, highlighting the importance of performance status and comorbidities in predicting treatment tolerance and outcomes in elderly cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Chemotherapy-Related Toxicity and Adverse Events in Elderly Thai Cancer Patients: A Prospective Study. Phaibulvatanapong, E., Srinonprasert, V., Ithimakin, S.[2018]

A frailty index developed from patient-reported geriatric assessments can effectively identify older adults with cancer who are at higher risk for worse overall survival, functional decline, and severe treatment-related toxicities, based on a study of 589 patients with a median age of 69.

Specifically, frail patients had a 1.83 times higher risk of mortality and were three times more likely to experience significant functional decline and severe non-hematologic toxicities compared to robust patients, highlighting the importance of assessing frailty in cancer treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported geriatric assessment-based frailty index among older adults with gastrointestinal malignancies. Giri, S., Al-Obaidi, M., Harmon, C., et al.[2023]

A predictive model for chemotherapy toxicity in older adults was validated in a study of 250 patients aged 65 and older, showing that 58% experienced significant toxicity (grade ≥ 3).

The model effectively stratified risk levels, with higher risk scores correlating with increased toxicity rates (36.7% low, 62.4% medium, 70.2% high risk), suggesting it can help guide treatment decisions for older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. Hurria, A., Mohile, S., Gajra, A., et al.[2022]

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]

The article emphasizes a personalized approach to managing cancer in older adults, taking into account their functional age and individual social and emotional needs, which is crucial given the complexities of aging and cancer.

An algorithm is proposed for assessing older cancer patients, focusing on evaluating life expectancy, the impact of cancer on survival and quality of life, and weighing the benefits and risks of treatments, which can help guide clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Cancer in the Older Age Person: An Approach to Complex Medical Decisions. Vallet-Regí, M., Manzano, M., Rodriguez-Mañas, L., et al.[2018]

There is currently no standard tool to assess the 'functional age' of older adults with cancer, highlighting the need for a comprehensive geriatric assessment that considers various factors affecting their health.

Integrating geriatric assessments into oncology can identify vulnerabilities and improve understanding of older patients' needs, ultimately leading to better-targeted interventions and improved cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment in oncology practice. Hurria, A.[2021]

Biological age, which reflects accumulated damage and vulnerability in individuals, plays a crucial role in managing cancer treatment and outcomes, especially in midlife and late-life patients, as it can influence their ability to tolerate therapies and their overall health.

Several biological age measures, such as p16INK4a and telomere length, show promise in oncology research, but more studies are needed to determine their practical application in personalizing cancer treatment and improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying a Life Course Biological Age Framework to Improving the Care of Individuals With Adult Cancers: Review and Research Recommendations. Mandelblatt, JS., Ahles, TA., Lippman, ME., et al.[2023]

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

Developing a cancer-specific geriatric assessment: a feasibility study. [2010]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Optimising Clinical Trial Design in Older Cancer Patients. [2020]

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

Evaluating the older patient with cancer: understanding frailty and the geriatric assessment. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Analysis of prognostic factors of comprehensive geriatric assessment and development of a clinical scoring system in elderly Asian patients with cancer. [2022]

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

Medication risks in older patients (70 +) with cancer and their association with therapy-related toxicity. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Factors for Chemotherapy-Related Toxicity and Adverse Events in Elderly Thai Cancer Patients: A Prospective Study. [2018]

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

Patient-reported geriatric assessment-based frailty index among older adults with gastrointestinal malignancies. [2023]

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

Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Developing a comprehensive cancer specific geriatric assessment tool. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Management of Cancer in the Older Age Person: An Approach to Complex Medical Decisions. [2018]

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

Geriatric assessment in oncology practice. [2021]

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

Applying a Life Course Biological Age Framework to Improving the Care of Individuals With Adult Cancers: Review and Research Recommendations. [2023]

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

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