Geriatric Assessment for Older Adults with Cancer

(PGA Trial)

Overseen By Karen Craver

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Under 65, Hormonal therapy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on improving cancer care for older adults by using a Practical Geriatric Assessment (PGA) to identify their strengths and vulnerabilities before starting certain cancer therapies. The researchers aim to determine if training and support for clinic staff can better prepare them to deliver these assessments, enhancing the quality of life and reducing side effects in patients aged 65 and older. It is ideal for those beginning new chemotherapy, immunotherapy, or targeted therapy. Participants should be willing to take part in interviews or surveys about their experiences. As an unphased trial, this study offers a unique opportunity to contribute to research that seeks to improve cancer care for older adults.

Do I need to stop taking my current medications to join the trial?

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 Practical Geriatric Assessment (PGA) is safe for older adults with cancer?

Research shows that using a Practical Geriatric Assessment (PGA) is generally safe for older adults with cancer. The PGA assesses the health and needs of seniors. Studies have found it helps identify strengths and weaknesses in older patients without causing harm.

No reports of serious side effects from the PGA exist because it is an assessment method, not a treatment. It involves asking questions and gathering information about the patient's physical health, mental health, and daily life. The goal is to improve care quality without adding risk.

Organizations like the American Society of Clinical Oncology (ASCO) recommend geriatric assessments for older adults with cancer to improve outcomes, indicating wide agreement on the safety and benefits of these assessments.

Overall, the PGA is well-tolerated, with no significant adverse events reported, making it a safe option for older adults undergoing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Assessment for Older Adults with Cancer trial because it aims to tailor cancer care specifically for older individuals through Practical Geriatric Assessment (PGA). Unlike standard treatment approaches that may not fully consider an older patient's unique health profile, PGA focuses on understanding their overall health, potential barriers, and specific needs. By integrating this personalized assessment into cancer care, the trial hopes to improve treatment outcomes and quality of life for older adults with cancer.

What evidence suggests that the Practical Geriatric Assessment is effective for older adults with cancer?

Research shows that geriatric assessments (GAs) can enhance cancer care for older adults. Studies have found that GAs improve communication between patients and doctors and increase satisfaction for both patients and caregivers. These assessments also help tailor chemotherapy doses to better fit an older adult's needs, potentially reducing side effects. Evidence supports that these assessments can positively affect treatment outcomes for older adults with cancer. This trial evaluates the Practical Geriatric Assessment (PGA) to make these assessments more accessible and easier to use in cancer clinics. ^{2 4 6 7 8}

Who Is on the Research Team?

Kathryn Weaver, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for oncology clinicians and support staff involved in administering new systemic therapies to patients aged 65 or older, as well as the patients themselves. Clinicians must be willing to participate in an interview and able to speak English. Support staff assisting with patient care workflows are also eligible.

Inclusion Criteria

I am willing to do a 60-minute interview online or by phone.

I can be in the URCC-19170 study at the same time.

I can read, understand, and speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Stakeholder Interview

Participants complete a stakeholder interview to gather information on current PGA relevant processes and provide feedback on proposed implementation strategies.

Up to 6 months

1 visit (in-person or virtual)

Part 2: PGA Education and Management

Clinic Champions and staff participate in an orientation session and receive education on PGA delivery. Practices start or increase PGA management for patients starting new non-hormonal systemic cancer therapy.

6 months

Monthly virtual meetings

Follow-up

Participants are monitored for the effectiveness of PGA implementation strategies and patient feedback is collected.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Practical Geriatric Assessment (PGA)

Trial Overview The study tests whether training and support for cancer clinic staff can improve the delivery of a specialized check-up (PGA) for older adults starting non-hormonal systemic cancer therapy. It evaluates how clinics adopt this practice without extra training.

How Is the Trial Designed?

Group I: Part 2 (PGA education, management, and support EHR review) Experimental Treatment 6 Interventions

See Detailed Description

Group II: Part 1 (stakeholder interview) Experimental Treatment 2 Interventions

Participants from practices selected for participation in Part 1 complete a stakeholder interview (approximately 60 minutes) to gather information on current PGA relevant processes within the practice, including any anticipated barriers or facilitators to delivery, and provide feedback on proposed implementation strategies.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06870617

Practical Geriatric Assessment (PGA) Implementation ... The PACE-70 study aims to evaluate PGA implementation and resultant chemotherapy dose modification among older adults with advanced cancer treated in a ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS1661

Practical geriatric assessment (PGA) implementation ... The primary outcome will be the PGA completion rate. The secondary outcome will be the rate of chemotherapy dose modification among those with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879406825001638

Geriatric assessment in older adults with cancer: A global ... Furthermore, the use of GA in cancer care of older adults has been associated with increased patient and caregiver satisfaction and improved communication ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657378/

The value and effectiveness of geriatric assessments for ... 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 ...

5. onco-hema.healthbooktimes.org onco-hema.healthbooktimes.org/api/v1/articles/94081-geriatric-assessment-of-older-patients-with-cancer-recent-data-and-updated-recommendations.pdf

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 ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00933

Practical Assessment and Management of Vulnerabilities ... A GA should include high priority aging-related domains known to be associated with outcomes in older adults with cancer: physical and cognitive ...

7. geheg.net geheg.net/wp-content/uploads/2023/09/1-ASCOGuidelineUpdate2023.pdf

ASCO Guideline Updat To improve outcomes for older adults with cancer through recommendations for: (1) use of validated geriatric assessment (GA) tools and GA-guided ...

8. oncnursingnews.com oncnursingnews.com/view/asco-states-that-all-older-adults-with-cancer-should-receive-geriatric-assessments

ASCO States That All Older Adults With Cancer Should ... All patients with cancer who are 65 years or older should receive a geriatric assessment (GA) to identity vulnerabilities or impairments ...