NCT06987890

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; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2025Jun 2026

First Submitted

Initial submission to the registry

May 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2026

Last Updated

March 5, 2026

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

May 16, 2025

Last Update Submit

March 3, 2026

Conditions

Keywords

Lung CancerGeriatric

Outcome Measures

Primary Outcomes (1)

  • Rate of referral to recommended supportive care services

    The primary endpoint for this study will be rate of referral to recommended supportive care services as compared to reported rates in historical cohorts, one month after PGA intervention.

    One-month post PGA Implementation

Secondary Outcomes (1)

  • Patient acceptance of PGA usage

    One-month post PGA Implementation

Study Arms (2)

PGA IMPLEMENTED IN NSCLC WITH SBRT

EXPERIMENTAL

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.

Other: Practical Geriatric Assessment

SUPPORTIVE CARE WITHOUT PGA IN NSCLC WITH SBRT

NO 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.

Interventions

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.

Also known as: PGA
PGA IMPLEMENTED IN NSCLC WITH SBRT

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Prostaglandins A

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

ProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiation Oncology

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 23, 2025

Study Start

May 26, 2025

Primary Completion (Estimated)

June 26, 2026

Study Completion (Estimated)

June 26, 2026

Last Updated

March 5, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations