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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist older adults who have had cancer. It examines whether a program involving health check-ups and coaching from a community worker (known as Geriatric Assessment and Promotora Coaching) can enhance their well-being. This focus is crucial because many older cancer patients face additional health issues that remain unaddressed after treatment. Suitable participants are those aged 65 to 90, who have received treatment for stage II-III breast, colorectal, or prostate cancer within the last year and reside near UC Davis Health. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve post-treatment care for older cancer survivors.

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 prior data suggests that this geriatric assessment and coaching method is safe for older adults with cancer?

Research has shown that geriatric assessments are generally safe for older adults with cancer. These assessments help reduce side effects from cancer treatments by identifying areas where older adults might be at risk, enabling doctors to manage health issues more effectively.

Geriatric assessments, like the one in this study, aim to improve overall well-being. They are not treatments themselves but tools to guide care. The coaching part of the program enhances participants' well-being by providing personalized health advice.

Past studies suggest that using geriatric assessments and personalized coaching is well-tolerated. No significant reports of harm or negative effects have emerged from these programs, indicating that the approach is safe for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment and Promotora Coaching approach because it offers a personalized strategy for supporting older adults with cancer. Unlike traditional cancer treatments that focus solely on the medical aspects, this approach emphasizes a comprehensive assessment of a patient's overall health and well-being, addressing issues like mobility, nutrition, and mental health. Additionally, the Promotora Coaching component introduces a culturally sensitive support system that empowers patients through education and advocacy, which is not usually a focus in standard cancer care. By integrating these elements, the treatment aims to enhance the quality of life and potentially improve outcomes for geriatric cancer patients.

What evidence suggests that this geriatric assessment and coaching program is effective for older adults with cancer?

Research has shown that assessing the overall health of older adults with cancer and providing guidance can be very beneficial. One small study with breast cancer patients aged 70 and older found that conducting a full health check every three months improved their health 87% of the time. This method works by regularly evaluating various aspects of a person's health and offering tailored advice. Other studies have found that such health checks can enhance the quality of life for older adults undergoing cancer treatment. Overall, this approach is recommended to improve care for older cancer patients.

In this trial, all enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention to evaluate its feasibility and effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Alex Fauer, PhD MS

Principal Investigator

UC Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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) 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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06125145

Study Details | NCT06125145 | Geriatric Assessment and ... 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 ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-1-2024-3a2f2

Geriatric Assessment + Coaching for Cancer (GAP Trial) 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40818480/

Effectiveness of comprehensive geriatric assessment with ... The aim of the G-oncoCOACH study is to evaluate the effectiveness of CGA on QoL in older patients with solid tumours receiving systemic therapy ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37738290/

Effectiveness of geriatric assessment and management in ... Comprehensive geriatric assessment and management is recommended to optimize cancer treatment, but its effect on various outcomes remains ...

5. onco-hema.healthbooktimes.org onco-hema.healthbooktimes.org/article/94081

Geriatric Assessment of Older Patients with Cancer This paper focuses on recent data demonstrating the benefits of GA and GA-driven interventions on clinical outcomes of geriatric patients with cancer.

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

Geriatric assessment for older people with cancer: policy ... An overview is given of the recommended approach for older people with cancer and its benefits on clinical outcomes and cost-effectiveness. In ...

7. youtube.com youtube.com/watch?v=guUR4m0054I

Improving Cancer Care for Older Adults: The Role of Geriatric ... Our research indicates that assessing older adults for potential areas of vulnerability can improve treatment tolerability.

8. oncnursingnews.com oncnursingnews.com/view/geriatric-assessment-intervention-helps-reduce-symptom-burden-for-older-patients-with-advanced-cancer

Geriatric Assessment Intervention Helps Reduce Symptom ... Providing oncologists with a baseline geriatric assessment summary with guidelines to manage toxicities may help reduce symptom burden in older ...