Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy

NCT ID: NCT06987890

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2026-06-26

Brief Summary

National guidelines recommend that older adults with cancer undergo a special health assessment before starting cancer treatment. This type of assessment evaluates physical function, nutrition, social support, psychological well-being, medical conditions (both cancer-related and non-cancer-related), and cognitive function. The results can help doctors make better treatment decisions and determine whether additional support services-such as nutrition counseling, physical therapy, or social work-would be beneficial. Even though these assessments are recommended, they are not typically used because they need to be performed by a specialist and can take over an hour to complete. Given these challenges, a 10-15-minute assessment called the Practical Geriatric Assessment (PGA) was recently developed. The PGA can be completed by any healthcare provider and helps identify older adults who may need extra support alongside their cancer treatment. While the PGA has the potential to make geriatric assessments more accessible, the investigators do not yet know whether patients will find it useful or easy to complete.

Additionally, it is unclear whether using the PGA will lead to more referrals for recommended supportive care services. This study aims to address these questions. The investigators will evaluate whether using the PGA impacts the number of patients referred to recommended supportive care services. Investigators will also evaluate how participants feel about completing the PGA, including how easy or difficult it is, and to assess the feasibility of implementing this survey on a larger scale. Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services.

Detailed Description

Comprehensive geriatric assessment (CGA) is one proven mechanism for delineating baseline care needs and improving outcomes in older adults with lung cancer. This type of geriatrician-led assessment, which captures functional ability, health, and socio-environmental situation, can be used to identify vulnerable older adults for whom tailored interventions might optimize care. However, CGA can be resource-intensive to perform, and may not practically possible in all settings, particularly given national shortages in geriatricians. At BWH/DFCI, retrospective work among patients with stage I-II NSCLC suggests fewer than 5% of patients receive CGA, despite 76% meeting national guidelines for this type of evaluation. These findings underscore the practical challenges of assessing geriatric needs, even in high-resource settings.

To address these barriers, abridged instruments capturing the key domains of the CGA which can be completed by any provider within 10-25 minutes have recently been developed, including the practical geriatric assessment (PGA) tool. This screening tool, which is now recommended by American Society of Clinical Oncology (ASCO), the International Society for Geriatric Oncology (SIOG), and the Cancer & Aging Research Group (CARG), has the potential capacity to delineate relevant baseline features in geriatric populations without creating undue provider burden. However, the feasibility of implementing the PGA and its acceptability to patients remain unclear. Further, relationships between the PGA and salient outcomes, including subsequent patterns of recommended care delivery, remain underexplored. To improve outcomes among high-risk subgroups interfacing with radiation oncology, including older adults with NSCLC undergoing SBRT, further interrogation of these practical factors is needed.

Finally, the investigators will use facial photographs and audio-visual data from the PGA to develop and evaluate artificial intelligence algorithm(s) to identify vulnerable patients who might benefit from additional supportive care services.

Conditions

Lung Cancer (NSCLC); Geriatric Assessment; Stereotactic Body Radiation Therapy (SBRT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PGA IMPLEMENTED IN NSCLC WITH SBRT

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 Type: EXPERIMENTAL

Practical Geriatric Assessment

Intervention Type: OTHER

The Practical Geriatric Assessment (PGA) is an abridged version of the Comprehensive Geriatric Assessment (CGA). This tool can be completed by any provider within 10-25 minutes while still capturing the key domains of the CGA. This screening tool, which is now recommended by American Society of Clinical Oncology (ASCO), the International Society for Geriatric Oncology (SIOG), and the Cancer \& Aging Research Group (CARG), has the potential capacity to delineate relevant baseline features in geriatric populations without creating undue provider burden.

SUPPORTIVE CARE WITHOUT PGA IN NSCLC WITH SBRT

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Practical Geriatric Assessment

The Practical Geriatric Assessment (PGA) is an abridged version of the Comprehensive Geriatric Assessment (CGA). This tool can be completed by any provider within 10-25 minutes while still capturing the key domains of the CGA. This screening tool, which is now recommended by American Society of Clinical Oncology (ASCO), the International Society for Geriatric Oncology (SIOG), and the Cancer \& Aging Research Group (CARG), has the potential capacity to delineate relevant baseline features in geriatric populations without creating undue provider burden.

Intervention Type: OTHER

Other Intervention Names

PGA

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years old at time of study enrollment.
• Radiographically or pathologically confirmed stage I-II non-small cell lung cancer.
• All patients must have undergone appropriate complete imaging of their cancer consistent with the standard of care.
• Patient is expected to undergo stereotactic body radiation therapy (SBRT)
• Able to read questions in English or willing to complete survey questionnaires with the assistance of an interpreter.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Raymond Mak

Associate Professor of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Raymond Mak

Role: primary

rmak@partners.org

6177328651

Other Identifiers

25-009

Identifier Type: -

Identifier Source: org_study_id