Geriatric Assessment for Non-Small Cell Lung Cancer

(Lung-GAP Trial)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

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

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a quick health check-up, called the Practical Geriatric Assessment (PGA), can help older adults with non-small cell lung cancer receive additional care they might need. The PGA is a brief test assessing physical health, nutrition, and social support, and any healthcare provider can conduct it. Researchers seek to understand if using the PGA results in more referrals for supportive care, such as nutrition advice or physical therapy, and how patients perceive this assessment. The trial seeks participants aged 65 and older with stage I-II non-small cell lung cancer who plan to undergo a specific type of radiation treatment.

As an unphased trial, this study offers participants the chance to contribute to research that could enhance supportive care for future patients.

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 seems focused on assessing your overall health and support needs, so it's best to ask the trial coordinators for specific guidance.

What prior data suggests that the Practical Geriatric Assessment is safe for use in older adults with cancer?

Research has shown that the Practical Geriatric Assessment (PGA) safely helps doctors understand the needs of older adults with cancer. The PGA is a quick and easy check-up that any healthcare provider can perform. It identifies patients who might need extra support, such as dietary advice or exercise assistance.

Past studies have used similar check-ups without causing harm to patients. These tools improve care by highlighting each patient's needs. While the PGA is not a treatment, it helps doctors customize care to enhance outcomes for older patients with non-small cell lung cancer. No reports of unwanted effects have emerged from using this type of assessment, indicating it is safe and well-tolerated for older adults with cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Practical Geriatric Assessment (PGA) for non-small cell lung cancer because it offers a personalized approach to patient care. Unlike traditional treatments that may overlook the specific needs of older adults, PGA provides a comprehensive assessment of a patient's geriatric health, allowing for tailored recommendations. This method empowers healthcare providers by giving them insights into potential impairments and recommending specific referrals, which could lead to more targeted and effective care. By focusing on the unique health challenges of geriatric patients, PGA aims to improve outcomes and enhance the overall quality of care for older adults with this condition.

What evidence suggests that the Practical Geriatric Assessment is effective for non-small cell lung cancer?

Research has shown that thorough health check-ups can improve treatment for older adults with lung cancer. These check-ups assess various health areas, such as mobility and diet, to develop a more effective care plan. Recent studies have found that these check-ups can lead to better outcomes for individuals over 65 with cancer. This trial tests the Practical Geriatric Assessment (PGA), a faster version designed to make these benefits more accessible. In one arm of the trial, providers will receive PGA results and recommended referrals, potentially enhancing the treatment experience. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older with stage I-II non-small cell lung cancer, who are about to receive stereotactic body radiation therapy. They must have completed standard imaging of their cancer and be able to read English or use an interpreter for survey questionnaires.

Inclusion Criteria

My lung cancer is confirmed to be in the early stages (I or II).

I am scheduled for SBRT treatment.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Practical Geriatric Assessment (PGA) Implementation

Participants undergo the Practical Geriatric Assessment to evaluate their need for supportive care services

1 month

Weekly reminders for providers

Follow-up

Participants are monitored for referral rates to supportive care services and acceptance of PGA usage

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Practical Geriatric Assessment

Trial Overview The study tests a quick, practical geriatric assessment (PGA) that any healthcare provider can perform in 10-15 minutes. It evaluates if the PGA leads to more support service referrals and how patients feel about this process. The study also explores developing AI algorithms using data from the PGA.

How Is the Trial Designed?

Group I: PGA IMPLEMENTED IN NSCLC WITH SBRT Experimental Treatment 1 Intervention

Providers will be made aware of PGA results and all recommended referrals based on PGA results. Providers will be reminded weekly for up to one month regarding these recommendations.

Group II: SUPPORTIVE CARE WITHOUT PGA IN NSCLC WITH SBRT Active Control 1 Intervention

Though PGA questions will be completed to characterize baseline impairment, providers will not be notified of PGA results or recommended referrals based on PGA results. Providers will assess for geriatric impairment at their discretion, and will make any service referrals they deem necessary, also at their discretion.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987890

Practical Geriatric Assessment in Older Adults With Non- ... Comprehensive geriatric assessment (CGA) is one proven mechanism for delineating baseline care needs and improving outcomes in older adults with lung cancer.

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

Practical Assessment and Management of Vulnerabilities ... Based on recently published RCTs demonstrating significantly improved clinical outcomes, all older adults with cancer (65+ years old) receiving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9008713/

A Geriatric Assessment Intervention to Reduce Treatment ... Over 75% of all new non-small cell lung cancer (NSCLC) diagnoses are among adults ≥65 years of age (1). As lung cancer is generally a disease of older adults, ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT229581

Geriatric assessment to predict toxicity in elderly patients ... Results: 85 elderly patients with LA-NSCLC were assessed by CGA and classified into fit 37%, medium fit 48% and unfit 15%. Based on VES-13, 56% were considered ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2531043718301132

Elderly patients with advanced NSCLC: The value of ... The CGA is a valuable tool for treatment selection to provide information beyond performance status, identify predictors of morbidity and mortality, and balance ...

6. journalpulmonology.org journalpulmonology.org/en-elderly-patients-with-advanced-nsclc-articulo-S2531043718301132

Elderly patients with advanced NSCLC A scoring system was developed that classified lung cancer patients into low (10%), intermediate (40%) or high (60%) risk of grade 3–5 toxicity. The study ...