Geriatric Assessment for Older Cancer Patients

Overseen By Lisa Marie Lowenstein, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Dementia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the experience of older cancer patients considering or receiving chemotherapy. It focuses on how a Geriatric Assessment (GA) can enhance communication about age-related concerns, patient satisfaction, and quality of life. The trial will also evaluate the adoption of the GA in community oncology practices. Patients aged 65 and older who are considering a new chemotherapy plan are well-suited for this trial. As an unphased trial, this study offers patients the chance to contribute to research that could enhance cancer care for older adults.

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. It focuses on improving communication and care for older cancer patients considering chemotherapy.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Geriatric Assessment is safe for older cancer patients?

Research has shown that geriatric assessments are generally safe for older cancer patients. A meta-analysis, which combined data from several trials and included nearly 5,000 participants, found that these assessments were beneficial for older cancer patients and identified those who would benefit most from special care.

Recent studies indicate that using geriatric assessments can lead to better outcomes for older cancer patients. These assessments enhance communication about age-related health issues, improving the treatment experience for both patients and their caregivers.

No reports of serious side effects have emerged from using geriatric assessments in these studies. This suggests they are well-tolerated by older patients, providing reassurance about the safety of participating in a trial involving geriatric assessments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment (GA) for older cancer patients because it offers a personalized approach that goes beyond standard medical treatments. Unlike typical cancer care, which often focuses solely on the disease, GA evaluates the overall health and needs of older adults, considering factors like mobility, nutrition, and mental health. This holistic method aims to tailor cancer treatment plans to better fit the unique needs of older patients, potentially improving their quality of life and treatment outcomes. By integrating comprehensive geriatric assessments into cancer care, the hope is to make treatment decisions that are more informed and supportive for both patients and their caregivers.

What evidence suggests that Geriatric Assessment is effective for older cancer patients?

Research shows that geriatric assessment (GA), which participants in this trial will receive, benefits older cancer patients. Studies have found that GA enhances communication between patients, caregivers, and medical staff about age-related issues, leading to greater satisfaction for both patients and caregivers. GA also correlates with a better quality of life and fewer chemotherapy side effects. Additionally, evidence suggests that GA can help predict health outcomes like illness and death in older adults with cancer. Overall, GA appears promising in supporting older cancer patients during treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Lisa Marie Lowenstein, PhD, MPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for older adults with cancer who are considering or undergoing chemotherapy, and their caregivers. Participants must be over 18, fluent in English, and have access to a computer or smart device. Clinicians and practice staff can also join. Those planning to leave their practice within six months or unable to consent are excluded.

Inclusion Criteria

Practice Staff Participants: Have access to computer, laptop, tablet, or smart phone

I am 65 years old or older.

I am considering starting a new chemotherapy treatment.

Exclusion Criteria

Care Partner/Caregiver Participants: Unable to provide consent

I am unable to give consent.

Practice Staff Participants: Have plans to leave the practice in six months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Assessment (GA) Implementation

Clinical staff undergo training in GA and implement GA among older adult patients considering chemotherapy

12 months

Monthly assessments

Follow-up

Participants are monitored for the reach and effectiveness of GA implementation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Assessment

Trial Overview The study tests the effectiveness of Geriatric Assessment (GA) on improving communication about age-related concerns between patients/caregivers and healthcare providers, satisfaction with this communication, quality of life, and management of chemotherapy side effects.

How Is the Trial Designed?

Group I: Geriatric Assessment (GA) Experimental Treatment 1 Intervention

Clinical staff undergo training in GA and are provided with facilitation and support for one year as they implement GA among older adult patients (65+) considering chemotherapy and their care partners/caregivers.

Geriatric Assessment is already approved in United States, European Union for the following indications:

Approved in United States as Geriatric Assessment for:

• Improving communication about age-related concerns in older cancer patients
• Enhancing patient and caregiver satisfaction with communication about age-related concerns

Approved in European Union as Geriatric Assessment for:

• Identifying vulnerabilities in older cancer patients
• Informing cancer treatment decision-making
• Addressing impairments through appropriate interventions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 110 patients aged 70 and older undergoing Comprehensive Geriatric Assessment (CGA), 70% were found to have multiple health issues, highlighting the complexity of treating older cancer patients.

Despite the use of CGA and oncologist clinical judgment, neither method was effective in predicting unfavorable outcomes from cancer treatment, with a significant discrepancy noted between the two assessments in nearly 39% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting outcome in older patients with cancer: Comprehensive geriatric assessment and clinical judgment. Versteeg, KS., Looijaard, SMLM., Slee-Valentijn, MS., et al.[2021]

A comprehensive geriatric assessment (CGA) can effectively predict morbidity and mortality in older cancer patients, highlighting its importance in oncology care.

Incorporating a CGA into the evaluation process helps identify issues that may be overlooked, suggesting that it can significantly improve the quality of care for older adults with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment for older patients with cancer. Extermann, M., Hurria, A.[2022]

In a study of 202 older cancer patients, those with lower Mini Nutritional Assessment (MNA) and Mini Mental State Examination (MMSE) scores were less likely to complete chemotherapy, indicating that these assessments can help identify patients at higher risk for treatment complications.

The study found that patients with low MNA scores and high Groningen Frailty Index (GFI) scores had significantly increased mortality rates after starting chemotherapy, highlighting the importance of comprehensive geriatric assessments in predicting outcomes for elderly cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive value of geriatric assessment for patients older than 70 years, treated with chemotherapy. Aaldriks, AA., Maartense, E., le Cessie, S., et al.[2015]

A comprehensive geriatric assessment (CGA) in 65 elderly cancer patients revealed that many had undetected health issues, such as functional impairments and malnutrition, highlighting the importance of CGA in this population.

The study found that 40% of patients experienced depression and 51% had mild cognitive impairment, indicating that CGA can help identify critical areas of concern that may affect treatment tolerance and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment in Korean elderly cancer patients receiving chemotherapy. Kim, YJ., Kim, JH., Park, MS., et al.[2021]

A study involving 494 elderly cancer patients (median age 75) found that three specific items from the Mini Nutritional Assessment (MNA) can predict the feasibility of chemotherapy, helping to streamline patient assessments.

The Geriatric Prognostic Index (GPI), based on three items, effectively identifies elderly patients at higher risk for mortality, with increasing hazard ratios indicating greater risk with more positive items.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors for the feasibility of chemotherapy and the Geriatric Prognostic Index (GPI) as risk profile for mortality before chemotherapy in the elderly. Aaldriks, AA., Maartense, E., Nortier, HJ., et al.[2016]

A new cancer-specific Comprehensive Geriatric Assessment (CGA) was developed for older cancer patients, which was completed by 99 participants with a mean age of 78.65 years in an average time of 12.9 minutes.

Most patients found the CGA to be satisfactory in length and easy to complete, indicating its feasibility as a tool for assessing the needs of older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a cancer-specific Comprehensive Geriatric Assessment in a University Hospital in Spain. Molina-Garrido, MJ., Guillén-Ponce, C.[2022]

A study involving 494 elderly cancer patients (median age 75) found that three specific items from the Mini Nutritional Assessment (MNA) can predict the feasibility of chemotherapy, helping to streamline patient assessments.

The Geriatric Prognostic Index (GPI), based on three items, effectively identifies elderly patients at higher risk for mortality, with increasing hazard ratios indicating greater risk with more positive items.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic factors for the feasibility of chemotherapy and the Geriatric Prognostic Index (GPI) as risk profile for mortality before chemotherapy in the elderly. Aaldriks, AA., Maartense, E., Nortier, HJ., et al.[2022]

The Comprehensive Geriatric Assessment (CGA) program at Metro North Hospital identified health issues in older cancer patients, with 59% of the 1380 patients screened showing impairments that warranted further assessment.

The most common issues found through CGA included mobility problems, malnutrition, polypharmacy, and low mood, indicating that tailored interventions can significantly support older patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our experience of nursing/allied health practitioner led geriatric screening and assessment of older patients with cancer - a highly accessible model of care. Thaker, DA., McGuire, P., Bryant, G., et al.[2021]

A comprehensive geriatric assessment (CGA) is increasingly recognized as a valuable tool for evaluating the overall health of elderly cancer patients, which can aid in treatment decisions and predict outcomes.

While CGA shows promise in oncology, there are practical challenges in its application that may affect its integration into standard clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comprehensive geriatric assessment in oncology: promises, pitfalls, and practicalities. Horgan, AM., Knox, JJ., Alibhai, SM.[2015]

The comprehensive geriatric assessment (CGA) utilized various tests to evaluate the health and functional status of older cancer patients, highlighting areas of limitation in their care.

Most CGA recommendations focused on general cancer treatment strategies, with additional emphasis on fall prevention and education, indicating a holistic approach to managing the health of elderly patients in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Geriatric Assessment: Interprofessional Team Recommendations for Older Adult Women With Breast Cancer Overcash, J.[2019]

Citations

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

Geriatric assessment for older people with cancer: policy ... Frailty screening methods for predicting outcome of a comprehensive geriatric assessment in elderly patients with cancer: a systematic review.

2. uptodate.com uptodate.com/contents/comprehensive-geriatric-assessment-for-patients-with-cancer

Comprehensive geriatric assessment for patients with cancer INTRODUCTION. Approximately 54 percent of new cases and 70 percent of mortality from cancer occur in patients ≥65 years of age [1,2].

3. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(25)00062-5/fulltext

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 ...

4. 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 ...

5. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2007.10.6559

Comprehensive Geriatric Assessment for Older Patients ... The evidence from recent studies demonstrates that a CGA can predict morbidity and mortality in older patients with cancer. Accumulating data show the benefits ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4308946/

Comprehensive geriatric assessment in the older cancer ... In a meta-analysis of 28 trials analyzing 4959 subjects, the CGA was shown to be effective at identifying patients who benefited from Geriatric Evaluation and ...

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

Geriatric Assessment: ASCO Global Guideline This clinical practice guideline addresses four overarching clinical questions posed in the 2023 Maximal-setting guideline update, with the ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406824001152

Evaluation of comprehensive geriatric assessment for older ... In pancreaticobiliary cancers, 70–80% of patients were diagnosed with an advanced stage, and the prognosis was poor compared to cancer of other organs.