Geriatric Assessment for Throat Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Metastatic cancer, Under 60, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized care plan, based on a thorough geriatric assessment, can better support older patients with head and neck cancer during treatment compared to usual care. The focus is on managing side effects and improving quality of life for both patients and their family caregivers. Participants should have a diagnosis of non-metastatic head and neck cancer and be about to start chemotherapy and radiation. This trial may suit those aged 60 and older who are concerned about the challenges of cancer treatment and support at this stage in life. As an unphased trial, it offers a unique opportunity to contribute to innovative care strategies tailored for older adults.

Do I need to stop my current medications for this 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 is safe for older patients with head and neck cancer?

Research has shown that geriatric assessments (GAs) are generally safe and well-tolerated. These assessments evaluate the physical, mental, and emotional health of older adults with cancer. Studies have found that GAs can help manage side effects better and improve the quality of life for older patients undergoing cancer treatment.

The geriatric assessment method is highly regarded for identifying patients at high risk of negative outcomes. This approach customizes care to meet each patient's specific needs, reducing the chance of severe side effects. Overall, evidence suggests that this method is safe for older adults and may offer significant benefits during their treatment journey. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized health communication can enhance throat cancer care for older adults. Unlike standard treatments, which focus solely on medical interventions like surgery, radiation, or chemotherapy, this approach uses geriatric assessments to tailor supportive care to each patient's needs. By evaluating patients and sharing results with oncologists, the trial aims to improve overall care by addressing issues like nutrition, mental health, and caregiver support, potentially leading to better outcomes and quality of life for patients.

What evidence suggests that the Practical Geriatric Assessment is effective for managing treatment-related side effects in older patients with head and neck cancer?

This trial will compare a GA-driven intervention with usual care for older adults with throat cancer. Research has shown that special check-ups for older adults with cancer, known as geriatric assessments, can be very helpful. These check-ups help doctors determine the extra support patients might need. Studies indicate that using these assessments can improve survival rates and overall health. They also help reduce hospital visits and keep patients more active. Overall, geriatric assessments appear to make cancer treatment easier and more effective for older patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Arya Amini

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults with head and neck cancer undergoing chemotherapy and radiation, along with their family caregivers. It's focused on those who may benefit from a specialized geriatric assessment to manage treatment side effects better.

Inclusion Criteria

Documented written informed consent of the participant

I am 60 years old or older.

Patients must have at least one geriatric assessment as assessed by the modified Geriatric 8 (G8) tool

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chemotherapy and radiation therapy for head and neck cancer, with geriatric assessment-based management or usual care

Up to 3 months

Regular clinical visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related toxicities and self-reported outcomes

3 months

Follow-up visits at 1 and 3 months

Open-label extension (optional)

Participants may continue to receive supportive care services based on geriatric assessment recommendations

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Health Communication
• Practical Geriatric Assessment

Trial Overview The study tests if a detailed geriatric assessment-based management improves the care of older patients during cancer treatment compared to standard supportive care. This includes health communication, interviews, best practices, office visits, and questionnaires.

How Is the Trial Designed?

Group I: Arm A (GA-driven intervention) Experimental Treatment 7 Interventions

Patients undergo PGA at baseline, at 4 weeks and at 1 month after completing treatment. Assessment results shared with treating oncologists and patients receive referrals to supportive care services for the problems identified with the assessment throughout the study. Caregivers may receive referrals to resources and programs.

Group II: Arm B (usual care) Active Control 5 Interventions

Patients attend regular clinical visits for treatment and follow up and receive usual care provided by their radiation oncology and medical oncology teams and referrals to supportive care services as needed throughout the study.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9265581/

Effectiveness of Geriatric Assessment-Driven Interventions on ... Effectiveness of geriatric assessment-driven interventions on survival and functional and nutritional status in older patients with head and neck cancer.

2. 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.

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

Practical Assessment and Management of Vulnerabilities ... All patients with cancer age 65 years and over with GA-identified impairments should have GA-guided management (GAM) included in their care plan ...

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. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2784405

Geriatric Assessment–Driven Intervention (GAIN) on ... Geriatric assessment–driven intervention can reduce mortality, hospitalizations, and functional decline in the general older adult population.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07225855

Geriatric Assessment and Management for Older Adults ... This clinical trial compares the effect of geriatric assessment (GA)-based management of supportive care to usual care in treating older ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9957492/

Practical Implementation of the Comprehensive Geriatric ... The CGA is the gold standard in geriatric oncology to identify patients at a high risk of adverse outcomes and optimize cancer and overall ...

8. 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 ...

9. ascopubs.org ascopubs.org/doi/10.1200/GO-25-00276

Geriatric Assessment: ASCO Global Guideline This clinical practice guideline addresses four overarching clinical questions posed in the 2023 Maximal-setting guideline update, with the ...