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

Trial Summary

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 data supports the effectiveness of the treatment Comprehensive Geriatric Assessment for breast cancer survivors?

Research shows that Comprehensive Geriatric Assessment (CGA) helps identify health issues in older breast cancer survivors, allowing for tailored care plans that maintain their functional status and improve quality of life. In a study, CGA improved patients' quality of life scores and maintained their independence, highlighting its effectiveness in addressing multiple health problems. ^{1 2 3 4 5}

Is the Comprehensive Geriatric Assessment safe for older adults, including breast cancer survivors?

The Comprehensive Geriatric Assessment is generally considered safe for older adults, including those with a history of breast cancer, as it helps identify care needs and develop plans to maintain their health. ^{1 3 6 7 8}

How is the treatment Comprehensive Geriatric Assessment different from other treatments for breast cancer survivors?

Comprehensive Geriatric Assessment is unique because it systematically evaluates older breast cancer survivors to identify risks of functional decline, allowing for personalized care plans to maintain their independence and quality of life. Unlike standard cancer treatments, it involves a multidisciplinary team approach, including assessments by various specialists like physical therapists and nutritionists, to address the broader health needs of older patients. ^{1 3 7 9 10}

What is the purpose of this trial?

This trial studies the effect of a geriatric care survivorship intervention in improving the overall health of older adults who have completed curative treatment for stage I-III breast cancer. Geriatric assessment is the complete examination of an elderly individual, which includes a full valuation of the physical and mental conditions, as well as a check of emotional state. Geriatric assessment and survivorship visits after treatment may reduce health burdens and improve the well-being and quality of life of elderly patients with breast cancer. Researchers hope to improve the overall health of older adults who have undergone curative treatment for stage I-III breast cancer.

Research Team

Meghan Karuturi, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

As a caregiver, I can perform all needed study tasks.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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) 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The value of a comprehensive geriatric assessment for patient care in acutely hospitalized older patients with cancer. [2021]

2. 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]

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

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

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

A comprehensive geriatric intervention detects multiple problems in older breast cancer patients. [2019]

5. Switzerland 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of geriatric assessment in community oncology clinics. [2016]

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

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

8. France pubmed.ncbi.nlm.nih.gov

[Risk assessment in medical geriatric oncology]. [2019]

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

Models of Care in Geriatric Oncology. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Is "Geriatric" Assessment Just for Older Patients? [2021]