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

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

To improve patient-centered outcomes for older patients with cancer considering or receiving chemotherapy and their caregivers. To do this, the project team will (a) establish the effectiveness of GA on communication about age-related concerns, patient and caregiver satisfaction with communication about age-related concerns, quality of life, and patient-reported side effects of chemotherapy; (b) evaluate the success of the implementation strategies on the adoption, reach, and fidelity of implementing the GA in community oncology practices; and (c) identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients considering or receiving chemotherapy.

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 data supports the idea that Geriatric Assessment for Older Cancer Patients is an effective treatment?

The available research shows that Geriatric Assessment helps create personalized treatment plans for older cancer patients by identifying health issues that might affect their ability to handle cancer treatment. It is used to evaluate various aspects of a patient's health, such as their physical abilities, mental state, and social support, which can help doctors make better treatment decisions. This approach is becoming more common as it aids in predicting treatment outcomes and helps prevent negative effects from cancer treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Geriatric Assessment for older cancer patients?

Research shows that Comprehensive Geriatric Assessment (CGA) helps create personalized treatment plans for older cancer patients by identifying health issues that affect their ability to undergo and recover from cancer treatment. It also aids in decision-making and predicting outcomes, making it a valuable tool in managing cancer care for the elderly. ^{1 2 3 4 5}

What safety data exists for Geriatric Assessment in older cancer patients?

The Comprehensive Geriatric Assessment (CGA) is used to evaluate older cancer patients' functional status, comorbid conditions, cognition, nutrition, psychological state, social support, and medications. It helps detect health problems, predict survival, and assess chemotherapy tolerance. While specific safety data is not detailed, CGA is a well-established method to identify frailty and risks, aiding in treatment planning and improving patient outcomes. ^{2 6 7 8 9}

Is the Comprehensive Geriatric Assessment (CGA) safe for older cancer patients?

The Comprehensive Geriatric Assessment (CGA) is generally considered safe for older cancer patients. It involves evaluating various aspects of a person's health, such as their physical and mental abilities, other medical conditions, nutrition, and social support, to help guide their treatment. ^{2 6 7 8 9}

Is the treatment Geriatric Assessment a promising treatment for older cancer patients?

Yes, Geriatric Assessment is a promising treatment for older cancer patients. It helps doctors create personalized treatment plans by evaluating the patient's overall health, including their physical and mental abilities, nutrition, and social support. This approach can improve the patient's ability to handle cancer treatments and recover better. ^{1 2 4 7 10}

How is the Geriatric Assessment treatment different for older cancer patients?

The Geriatric Assessment treatment is unique because it evaluates various aspects of an older cancer patient's health, such as their physical function, mental state, nutrition, and social support, to create a personalized care plan. This approach helps identify issues that might affect their ability to undergo and recover from cancer treatment, unlike standard treatments that may not consider these factors. ^{1 2 4 7 10}

Research Team

Lisa Marie Lowenstein, PhD, MPH

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

My caregiver can read and speak English fluently.

I can read and speak English fluently.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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]

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]

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) 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 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]

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]

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]

References

1. Netherlands 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. [2021]

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

Comprehensive geriatric assessment for older patients with cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The comprehensive geriatric assessment in oncology: promises, pitfalls, and practicalities. [2015]

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

Predictive value of geriatric assessment for patients older than 70 years, treated with chemotherapy. [2015]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Predicting outcome in older patients with cancer: Comprehensive geriatric assessment and clinical judgment. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment in Korean elderly cancer patients receiving chemotherapy. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a cancer-specific Comprehensive Geriatric Assessment in a University Hospital in Spain. [2022]

8. England 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. [2022]

9. England 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. [2016]

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

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