Geriatric Assessment for Cancer Survivorship

Overseen By Joseph Mosholder

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Advanced dementia, Nursing home resident

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

Duration: 4-6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding a geriatric assessment visit improves the quality of life and satisfaction with care for older adults who have completed chemotherapy for cancer. Researchers aim to determine if this additional assessment by a geriatric nurse or doctor, alongside a survivorship care plan, makes a difference compared to the care plan alone. Suitable participants are those aged 65 or older who have completed chemotherapy intended to cure their cancer and are scheduled to receive a follow-up care plan. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance post-chemotherapy care for older adults.

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 adults?

Research has shown that geriatric check-ups are safe for older adults. These check-ups help identify health risks and potential treatment issues early. Studies indicate that older adults who undergo these check-ups tend to live longer and are more likely to remain in their own homes compared to those who do not. No major negative effects have been reported from the check-ups themselves, making them generally well-tolerated. In summary, geriatric check-ups appear to be a safe way to enhance care for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how comprehensive geriatric assessments can improve cancer survivorship care for older adults. Unlike standard cancer care, which often focuses on the tumor itself, this approach takes a holistic view of the patient by assessing various factors like physical health, mental wellness, and social needs. By involving geriatric specialists, the trial aims to tailor cancer treatments more effectively to the unique needs of older adults, potentially leading to better outcomes and quality of life for this age group.

What evidence suggests that a geriatric assessment is effective for improving quality of life in older cancer survivors?

Research has shown that thorough health check-ups for older adults, especially those with a history of cancer, might improve their quality of life. In this trial, participants in the active comparator arm will receive comprehensive geriatric assessments. Some studies suggest these assessments can lead to improved well-being several months after treatment. Evidence also indicates that these assessments can enhance communication with doctors and better address individual needs. However, the effect on overall survival and health-related quality of life can vary. Overall, these check-ups could help older cancer survivors manage their health and feel more satisfied with their care. ^{3 6 7 8 9}

Who Is on the Research Team?

Haifaa Abdulhaq, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who have finished chemotherapy with the goal of curing cancer. They must be scheduled to receive a survivorship care plan from an oncology navigator and able to participate in interviews. It's not for those with advanced dementia, serious cognitive issues, or nursing home residents.

Inclusion Criteria

I am 65 years old or older.

I have cancer and finished chemotherapy aimed at curing it.

I am scheduled to get a care plan from a cancer care specialist.

Exclusion Criteria

I live in a nursing home.

I do not have advanced dementia or serious cognitive issues that would prevent me from participating in an interview.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a survivorship care plan, with some receiving an enhanced plan including a geriatric assessment

4-6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for satisfaction, quality of life, and knowledge after receiving the survivorship care plan

4-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Geriatric Assessment

Trial Overview The study is testing if adding a geriatric assessment visit after giving older adults a survivorship care plan can improve their quality of life and satisfaction with care post-chemotherapy compared to just receiving the care plan alone.

How Is the Trial Designed?

Group I: No intervention arm Active Control 1 Intervention

routine care only; will not be scheduled for comprehensive geriatric assessment

Group II: Active comparator arm Active Control 1 Intervention

those that will be scheduled for comprehensive geriatric assessment with a geriatric nurse practitioner or physician

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Comprehensive geriatric assessment (CGA) is crucial for evaluating frail elderly cancer patients, as it considers various factors like functional, physical, and mental health, which can influence treatment outcomes.

By using CGA, healthcare providers can better identify which elderly patients are suitable for aggressive cancer treatment versus those who would benefit more from supportive care, potentially increasing their inclusion in clinical trials and improving their overall management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment. Wieland, D., Hirth, V.[2017]

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]

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]

Comprehensive geriatric assessment (CGA) is feasible in radiation oncology, with studies indicating that it can help identify vulnerable patients who may be at higher risk of mortality, as shown by significant associations in two studies.

While CGA may influence treatment decision-making, its impact on treatment tolerance was not statistically significant, suggesting that while it can help in patient selection, its role in improving treatment outcomes may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Comprehensive Geriatric Assessment and Geriatric Screening for Older Adults in the Radiation Oncology Setting: A Systematic Review. Szumacher, E., Sattar, S., Neve, M., et al.[2019]

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 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 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]

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) 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]

The pilot study involving 25 geriatric cancer patients showed that implementing a comprehensive geriatric assessment (CGA) in a busy oncology clinic is feasible, although it faced some logistical challenges.

Patients reported feeling grateful for the additional time and attention provided during the CGA process, highlighting its potential psychosocial benefits, even though only minor changes in health domains were observed from before to after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a comprehensive geriatric assessment tool in geriatric cancer patients undergoing adjuvant chemotherapy: a pilot study. Koneru, R., Freedman, O., Lemonde, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147235/

The effectiveness of comprehensive geriatric assessment ... Very low-quality evidence suggested improved quality of life in the CGA group at 3 and 12 months, as reported by Cohen (2002) and Puts (2018).

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

Geriatric assessment for older people with cancer: policy ... Clinical evidence exists on its benefits on outcomes such as toxicity rates, quality of life, mobility, patient centred-communication and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666756822001696

Articles Integrated Geriatric Assessment and Treatment ... The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24014

Effects of comprehensive geriatric assessment (CGA) ... The current models of CGA guided care did not improve OS and had variable effects on HRQL when compared to usual care in older patients with cancer.

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05607-9

The value and effectiveness of geriatric assessments for older ... GAs seems to be beneficial for older adults with cancer across some outcomes, with strong evidence demonstrating the impact of GA with management for treatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12019282/

Application of comprehensive geriatric assessment in ... CGA helps identify high-risk patients, anticipates potential treatment complications, and allows for ongoing monitoring during therapy, thereby reducing ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4164377/

Comprehensive geriatric assessment for older adults admitted ... Patients in receipt of CGA were more likely to be alive and in their own homes at up to six months (OR 1.25, 95% CI 1.11 to 1.42, P = 0.0002) and at the end of ...

9. esmoopen.com esmoopen.com/article/S2059-7029(24)01426-1/fulltext

Adequate assessment yields appropriate care—the role of ... Geriatric assessment and management (GAM) refers to the comprehensive evaluation of an individual's health status with subsequent management ...