Geriatric Care for Breast Cancer Survivors

Overseen By Meghan Karuturi, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Significant medical conditions, others

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

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health and well-being of older adults who have completed treatment for stage I-III breast cancer. It includes a Comprehensive Geriatric Assessment, which evaluates physical, mental, and emotional health. Participants will undergo this assessment at the start and several times over a year, with interventions tailored to their needs. This trial may suit individuals aged 65 or older who recently completed chemotherapy for breast cancer and are fluent in English or Spanish. As an unphased trial, it offers a unique opportunity to contribute to research focused on enhancing post-treatment care for older adults.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. It seems you can continue with certain treatments like radiation, HER-2 targeted agents, and endocrine therapy.

What prior data suggests that this geriatric care intervention is safe for breast cancer survivors?

Research has shown that the Comprehensive Geriatric Assessment (CGA) is safe and well-tolerated for older adults with cancer, including those with a history of breast cancer. Studies have found that CGA can predict treatment response and evaluate quality of life. Since it involves no medication, the assessment itself causes no side effects or negative reactions. Instead, it assesses physical, mental, and emotional health to guide future care. As a result, CGA is considered very safe for older individuals and can provide valuable information to enhance their health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Geriatric Assessment for breast cancer survivors because it offers a personalized and holistic approach to post-treatment care. Unlike standard follow-up regimens, which often focus primarily on monitoring for cancer recurrence, this method considers the overall health and well-being of older survivors through regular assessments and tailored interventions. This approach also incorporates the use of wearable activity tracking devices, which can provide real-time data on patients' physical activity, potentially leading to more dynamic and responsive care strategies. By focusing on the unique needs of older adults, this method aims to improve quality of life and address issues commonly overlooked in traditional care plans.

What evidence suggests that the Comprehensive Geriatric Assessment is effective for improving the health of older breast cancer survivors?

Research has shown that a Comprehensive Geriatric Assessment (CGA), which participants in this trial will undergo, can predict outcomes and enhance the quality of life for older breast cancer survivors. One study found that CGA identifies health issues that might impact treatment tolerance and long-term survival. By assessing both physical and mental health, CGA creates personalized care plans tailored to each person's needs. This approach has been linked to better management of health challenges and improved well-being. Overall, CGA offers a promising method to boost the health of older adults after cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Meghan Karuturi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for older adults who are at least 65 years old and have recently completed treatment for early-stage breast cancer (Stage I-III). They must be able to consent, speak English or Spanish, and meet all study requirements. Caregivers can also participate if they're over 18. People with significant medical conditions that prevent exercise participation cannot join.

Inclusion Criteria

Able to provide written, informed consent

I am willing and able to follow all study requirements.

I am 65 years old or older.

Exclusion Criteria

The presence of significant medical conditions that in the physician's (either the patient's primary oncologist of the study principal investigator) judgement preclude participation in the exercise intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a geriatric assessment to evaluate physical, mental, and emotional conditions

1 visit

1 visit (in-person)

Intervention

Participants receive a GA-guided intervention, survivorship care educational materials, and a wearable activity tracking device

12 months

3 visits (in-person) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, including assessments at 6 and 12 months

12 months

2 visits (in-person) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Geriatric Assessment
• Health Education
• Supportive Care

Trial Overview The trial is testing a geriatric care survivorship intervention aimed at improving health in elderly patients post-breast cancer treatment. It includes comprehensive assessments of physical and mental health, usage of medical devices, health education, and supportive care to enhance quality of life.

How Is the Trial Designed?

Group I: Supportive Care (GA-guided intervention) Experimental Treatment 4 Interventions

Patients complete geriatric assessments at baseline, 6 months, and 12 months later. Based on the assessments, patients may receive further intervention at survivorship visit. Patients also receive survivorship care educational materials and wear a wearable activity tracking device for 1 year on study.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Older breast cancer survivors are at risk for a decline in functional status, which can lead to increased disability, higher healthcare costs, and a greater likelihood of nursing home placement.

The comprehensive geriatric assessment is an effective tool for identifying these at-risk individuals, enabling nurses to create targeted care plans to help maintain their functional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Declining functional status in older women with a history of breast cancer: implications for women's health nurses. Talley, C., Talley, H.[2013]

In a study of 292 cancer patients aged 65 and older, a high prevalence of geriatric conditions was found, including instrumental ADL impairment (78%) and depressive symptoms (65%), indicating significant health challenges in this population.

Mortality rates were notably high, with 38% of patients dying within 3 months and 64% within 12 months, but mortality was primarily linked to cancer-related factors rather than geriatric conditions, suggesting that cancer severity may be a more critical determinant of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. Hamaker, ME., Buurman, BM., van Munster, BC., et al.[2021]

In a study of 550 patients with early breast cancer, geriatric assessment (GA) revealed that while older women had more overall deficits, younger patients exhibited higher levels of anxiety, indicating that GA can uncover important psychological factors in younger patients.

Suboptimal physical function was a significant issue for both younger and older patients, suggesting that GA is valuable for identifying major deficits in younger patients that may not be detected through standard evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is "Geriatric" Assessment Just for Older Patients? Aleixo, GFP., Choi, SK., Tan, AJ., 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]

Collaboration between oncologists and geriatricians is crucial for assessing risks in elderly cancer patients, focusing on vulnerability, potential death, and severe side effects from chemotherapy.

Utilizing comprehensive geriatric assessments and predictive scores allows for a thorough evaluation of elderly patients, helping to inform treatment decisions in a multidimensional way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. Pamoukdjian, F., Ferreira, A.[2019]

In a pilot study involving 15 early breast cancer patients aged 70 and older, a comprehensive geriatric assessment (CGA) every 3 months led to an 87% success rate in addressing various health problems, demonstrating its effectiveness in managing comorbidities.

The intervention resulted in improved quality of life, as indicated by an increase in mean Functional Assessment of Cancer Treatment-Breast (FACT-B) scores from 110.5 to 116.3, while also maintaining patients' function and independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive geriatric intervention detects multiple problems in older breast cancer patients. Extermann, M., Meyer, J., McGinnis, M., et al.[2019]

A systematic review of 18 studies involving 4734 breast cancer patients supports the use of comprehensive geriatric assessment (CGA) to identify factors that influence survival and quality of life, aiding in treatment decision-making.

While CGA shows promise in improving patient outcomes, there is still uncertainty regarding the best assessment tools to use, indicating a need for further research to establish a gold standard for CGA in breast cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Geriatric Assessment for Older Women with Early-Stage (Non-Metastatic) Breast Cancer-An Updated Systematic Review of the Literature. Reid-Agboola, C., Klukowska, A., Malcolm, FL., et al.[2023]

Incorporating geriatric assessment (GA) into cancer care for older adults is feasible and can predict treatment outcomes, highlighting the importance of tailored approaches for this age group.

Multidisciplinary teams, including geriatricians and other specialists, enhance the effectiveness of GA-guided interventions, ensuring comprehensive support for older cancer patients throughout their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of Care in Geriatric Oncology. Magnuson, A., Dale, W., Mohile, S.[2020]

A geriatric assessment (GA) tool can be effectively implemented in community oncology clinics, with 339 out of 1088 patients assessed in these settings, demonstrating its feasibility for older adults receiving cancer treatment.

The time taken to complete the GA was comparable between academic and community clinics, suggesting that this assessment can be integrated into routine care without significant delays, although more patients in community settings required assistance with the questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. Williams, GR., Deal, AM., Jolly, TA., 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]

Citations

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Comprehensive Geriatric Assessment for Older Women ... Our results have demonstrated that CGA can be successfully used to predicting outcomes and in the assessment of QoL in breast cancer patients. We have also ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05006482

Study Details | NCT05006482 | Geriatric Evaluation and ... This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care

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Geriatric Assessment in Older Patients with Breast Cancer In this review, we outline the essential components of a geriatric assessment, discuss screening tools for measuring the individual domains, and examine the ...

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Older Breast Cancer Survivors: Geriatric Assessment ... This study provides longitudinal evidence that GA domains are associated with poor treatment tolerance and predict mortality at 7 years of follow-up, ...

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Geriatric Assessment in Older Patients with Breast Cancer in Comprehensive geriatric assessment predicts tolerance to chemotherapy and survival in elderly patients with advanced ovarian carcinoma: a GINECO study. Ann ...

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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].

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406823001637

The association of the G8 questionnaire with treatment side ... A CGA can predict treatment tolerance, mortality, and three-year survival [6]. As demonstrated in multiple trials focused on older adults with cancer, a ...

8. mdpi.com mdpi.com/1718-7729/30/9/602

Comprehensive Geriatric Assessment for Older Women ... Our results have demonstrated that CGA can be successfully used to predicting outcomes and in the assessment of QoL in breast cancer patients. We have also ...