Geriatric Assessment for Cancer in Seniors with Frailty or Cognitive Impairment

Overseen By Damsadie Hannedige, BSc, MSc

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Long-term care resident, Urgent cases

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

150 Participants Needed

Trial Summary

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 effectiveness of the treatment Geriatric Assessment, Comprehensive Geriatric Assessment, CGA for seniors with frailty or cognitive impairment?

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 handle cancer treatment. It also aids in predicting treatment outcomes and improving the quality of cancer care in older adults. ^{1 2 3 4 5}

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

The Comprehensive Geriatric Assessment (CGA) is generally considered safe for older adults, as it helps identify health issues and tailor treatment plans without causing harm. ^{1 6 7 8 9}

How is the Geriatric Assessment treatment different from other treatments for cancer in seniors with frailty or cognitive impairment?

The Geriatric Assessment (CGA) is unique because it is a comprehensive method that evaluates multiple aspects of an elderly patient's health to detect frailty, helping doctors tailor cancer treatments specifically for older patients. Unlike standard treatments, CGA considers the overall health and vulnerabilities of seniors, making it the gold standard for assessing frailty in elderly cancer patients. ^{6 7 10 11 12}

What is the purpose of this trial?

This is a single center, non-blinded randomized control trial taking place at the Queen Elizabeth II hospital (QEII) in Nova Scotia. Patients are eligible if aged 75 and older scheduled for elective cancer surgery (proven cancer or highly suspicious cancer) and screened to have mild or greater frailty (with cognitive impairments) or moderate to greater frailty (with medical/physical conditions). Eligible participants will then be randomized to preoperative standard of care or geriatric assessment through the PATH clinic. Primary outcome will assess time spend at home at 6 months after the surgery.

Research Team

Richard Spence, MD, FRCSC

Principal Investigator

Queen Elizabeth II Health Sciences Center

Eligibility Criteria

This trial is for patients aged 75 or older who are scheduled for elective cancer surgery and have been identified as severely frail or cognitively impaired. They must consent to the surgery, not live in long-term care before their diagnosis, and cannot be urgent/emergent cases.

Inclusion Criteria

Informed consent for participation must be received

I have a confirmed diagnosis of cancer in the lung, throat, bone, reproductive organs, breast, or digestive system.

I am considered frail due to cognitive issues or physical health conditions.

Exclusion Criteria

Urgent/emergent cases are excluded.

Patients cannot be a resident in a long-term care facility prior to the cancer diagnosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo either standard preoperative assessment or PATH geriatric care assessment

1-2 weeks

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo cancer surgery and receive immediate postoperative care

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of time spent at home and other outcomes

6 months

Treatment Details

Interventions

• Geriatric assessment

Trial Overview The study compares standard preoperative care with a specialized geriatric assessment at the PATH clinic for elderly patients facing cancer surgery. The main goal is to see if this approach helps them spend more time at home after six months post-surgery.

Participant Groups

Group I: PATH geriatric care Experimental Treatment 1 Intervention

Pre-operative assessment through the PATH clinic

Group II: Standard of care Active Control 1 Intervention

Patients will undergo the usual preoperative assessment from preoperative clinic which includes standard general internal medicine and anesthesia assessment.

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

Approved in Canada as Geriatric Assessment for:

• Preoperative evaluation for frail older patients undergoing elective cancer surgery

Approved in European Union as Comprehensive Geriatric Assessment for:

• Preoperative evaluation for frail older patients undergoing surgery
• General health assessment for older adults

Approved in United States as Geriatric Assessment for:

• Preoperative evaluation for frail older patients undergoing surgery
• General health assessment for older adults

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

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]

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]

Comprehensive geriatric assessment (CGA) is a thorough evaluation that helps understand the overall health and needs of older cancer patients, considering factors like functional status, comorbidities, and social support.

Recent data indicates that CGA can effectively predict morbidity and mortality in older cancer patients, suggesting it could be beneficial in guiding interventions to enhance their cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oncogeriatrics: an attempt to operational definition]. De Breucker, S., Luce, S., Pepersack, T.[2009]

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]

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]

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]

In a study of 282 elderly cancer patients, the SAOP2 screening tool demonstrated better sensitivity for identifying frailty compared to the G8 tool, with an area under the curve (AUC) of 0.85 versus 0.79.

Both screening tools effectively identified frailty, but SAOP2 was particularly effective in breast cancer patients and those aged 70-80, indicating its potential for better clinical application in routine practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive values of two frailty screening tools in older patients with solid cancer: a comparison of SAOP2 and G8. Russo, C., Giannotti, C., Signori, A., et al.[2022]

In a study of 217 older patients (average age 83) with solid tumors, frailty markers such as grip strength and physical activity were found to significantly influence treatment recommendations in an oncogeriatric clinic.

The number of frailty markers and basic Activities of Daily Living (ADL) were strongly associated with treatment decisions, suggesting that assessing frailty could be crucial for optimizing cancer care in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frailty Markers and Treatment Decisions in Patients Seen in Oncogeriatric Clinics: Results from the ASRO Pilot Study. Farcet, A., de Decker, L., Pauly, V., et al.[2019]

Comprehensive Geriatric Assessment (CGA) is recommended as the gold standard for evaluating elderly cancer patients, but its adoption in oncology is slow due to practical challenges, highlighting the need for a more efficient assessment tool.

There is a significant gap in understanding the efficacy and safety of cancer treatments for frail elderly patients, indicating a need for more inclusive clinical trials and the development of a frailty index to better predict treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of elderly and frail elderly cancer patients: the importance of comprehensive geriatrics assessment and the need for guidelines. Ruiz, M., Reske, T., Cefalu, C., et al.[2022]

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

4. Belgium pubmed.ncbi.nlm.nih.gov

[Oncogeriatrics: an attempt to operational definition]. [2009]

5. England pubmed.ncbi.nlm.nih.gov

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

6. 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]

7. 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]

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

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

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Predictive values of two frailty screening tools in older patients with solid cancer: a comparison of SAOP2 and G8. [2022]

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

Frailty Markers and Treatment Decisions in Patients Seen in Oncogeriatric Clinics: Results from the ASRO Pilot Study. [2019]

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

Management of elderly and frail elderly cancer patients: the importance of comprehensive geriatrics assessment and the need for guidelines. [2022]