Geriatric Assessment + Coaching for Cancer

(GAP Trial)

Overseen By Alex Fauer, PhD MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

49 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.

What data supports the effectiveness of the treatment Geriatric Assessment and Promotora Coaching for cancer?

Geriatric assessment (GA) has been shown to improve outcomes like survival and quality of life in older patients, and when combined with management, it can reduce functional decline and healthcare use in non-cancer patients. In cancer care, GA can identify vulnerabilities and guide interventions, which has been shown to improve quality of life and maintain function in older cancer patients. ^{1 2 3 4 5}

Is the Geriatric Assessment + Coaching for Cancer safe for humans?

Research shows that geriatric assessments, when used in cancer care, can help reduce treatment-related side effects in older adults and are generally safe. They involve a team of healthcare professionals and focus on identifying and managing various health risks, ensuring coordinated care. ^{1 4 6 7 8}

How is the Geriatric Assessment + Coaching treatment for cancer different from other treatments?

The Geriatric Assessment + Coaching treatment is unique because it involves a comprehensive evaluation of an older adult's medical, psychological, social, and functional capacity to tailor cancer treatment specifically for their needs. This approach helps identify vulnerabilities and optimize treatment plans, which is not typically part of standard cancer treatments. ^{5 9 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to test a new way to help older adults who have had cancer. The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.

Research Team

Alex Fauer, PhD MS

Principal Investigator

UC Davis

Eligibility Criteria

This trial is for older adults aged 65-90 who have had Stage II-III breast, colorectal, or prostate cancer. They should have finished their main treatment within the last year and live in the UC Davis Health area. Participants must understand English or Spanish and have a caregiver aged 21-90.

Inclusion Criteria

I have a primary caregiver who is between 21 and 90 years old.

I am between 65 and 90 years old.

I understand and can follow the study's procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Geriatric Assessment

Community Health Worker conducts a geriatric assessment including screening for frailty, cognition, polypharmacy, depression, symptom burden, and social support.

1 month

1 visit (in-person)

Coaching

Community Health Worker delivers coaching based on the Problem Solving Coaching Model, providing tailored feedback and navigation to additional resources.

5 months

2 visits (in-person)

Follow-up

Participants are monitored for emotional support, depression, anxiety, fatigue, self-efficacy, physical function, and quality of life.

6 months

Treatment Details

Interventions

• Geriatric Assessment and Promotora Coaching

Trial Overview The study tests a health assessment program with coaching from community health workers (promotoras) to improve well-being in older cancer survivors. It aims to see if this approach is practical and beneficial for addressing additional health issues post-treatment.

Participant Groups

Group I: Feasibility Arm Experimental Treatment 1 Intervention

All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

Geriatric assessment (GA) is crucial for understanding the medical and supportive care needs of older adults with cancer, but its implementation with management strategies is not well established in this population.

There is a need for rigorous clinical trials to evaluate the effectiveness of GA with management in older cancer patients, as it has shown benefits in non-cancer populations, such as reducing functional decline and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management in cancer care: Current evidence and potential mechanisms for future research. Magnuson, A., Allore, H., Cohen, HJ., et al.[2022]

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 self-administered questionnaire designed for older cancer patients (aged 65 and older) effectively identified various health needs, including physical and psychological impairments, nutritional issues, and lack of social support, in a study involving 245 participants.

The questionnaire was well-received, with high acceptance rates regarding its length and content, suggesting it is a feasible tool for integrating geriatric assessments into cancer care, although further trials are needed to evaluate the effectiveness of the resulting interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. Hurria, A., Lichtman, SM., Gardes, J., et al.[2015]

A geriatric assessment (GA) intervention significantly reduced the incidence of moderate to severe symptomatic toxicity in older patients (age ≥ 70) with advanced cancer, as shown in a study of 706 patients.

Patients receiving the GA intervention reported fewer grade ≥ 2 symptoms compared to those receiving usual care (88.9% vs 94.8%), indicating that tailored management recommendations can improve patient experiences during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. Culakova, E., Mohile, SG., Peppone, L., 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]

Geriatric oncology focuses on the specialized management of older cancer patients, utilizing comprehensive geriatric assessments to address their complex medical needs.

Current research aims to identify key geriatric variables for clinical trials and develop screening tools to assess frailty in older cancer patients, ultimately improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. Terret, C., Gaujard, S., Droz, JP.[2009]

Geriatric assessment in oncology is feasible and typically takes 10-45 minutes, with certain assessment domains linked to treatment toxicity and mortality in older cancer patients.

While some studies suggest that geriatric assessment can influence treatment decisions in 40%-50% of cases, overall evidence on its impact on decision-making and outcomes remains limited, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of geriatric assessment for older adults in the oncology setting: a systematic review. Puts, MT., Hardt, J., Monette, J., et al.[2022]

References

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

Models of Care in Geriatric Oncology. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Geriatric assessment with management in cancer care: Current evidence and potential mechanisms for future research. [2022]

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

Adherence to geriatric assessment-based recommendations in older patients with cancer: a multicenter prospective cohort study in Belgium. [2020]

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

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

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

Identifying vulnerable older adults with cancer: integrating geriatric assessment into oncology practice. [2015]

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

Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. [2023]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

[Should older patients with cancer visit a geriatrician as well? The value of geriatric assessments]. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Geriatric assessment and the variance of treatment recommendations in geriatric patients with gastrointestinal cancer-a study in AIO oncologists. [2023]

10. France pubmed.ncbi.nlm.nih.gov

[Current views in geriatric oncology]. [2009]

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

Use of geriatric assessment for older adults in the oncology setting: a systematic review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Prospective Comparison of Geriatric Assessment and Provider's Assessment of Older Adults With Metastatic Breast Cancer in the Community. [2022]