Lung Cancer (NSCLC)Lung-GAPNCT06987890
Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy
A study testing Practical Geriatric Assessment in people with Lung Cancer (NSCLC) and Geriatric Assessment, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Geriatric Assessment, Stereotactic Body Radiation Therapy (SBRT)
- What is being tested?
- Practical Geriatric Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2025to 26 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Raymond Mak, 6177328651, rmak@partners.org
About this study
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.
Read the 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; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.
- Being tested
- Practical Geriatric Assessment
- Keywords
- Lung Cancer, Geriatric
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practical Geriatric AssessmentOther
Also called PGA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One-month post PGA Implementation
Secondary outcomes (1)
Patient acceptance of PGA usage
The secondary endpoint for this study will be patient acceptance of PGA usage, as quantified by scores on the Response Burden Questionnaire (RBQ).
Response Burden Questionnaire (RBQ). And to correlate domains of PGA with other measures of frailty/advanced age, including AI- based measures of biological including FaceAge, sit-to-stand test, and grip strength.
- How well did these questions relate to your actual concerns?
- 0 (not at all related) to 10 (very related)
- How well did these questions describe your health and well-being?
- 0 (not at all related) to 10 (very related)
- How comfortable were you in answering these questions?
- 0 (not at all related) to 10 (very related)
- How did you feel about the length of time to complete these questions?
- 1 (much too long), 2 (a bit too long), 3 (just right/no problem)
- What questions seemed unimportant or repetitive: ______________
- What additional information should we gather? __________________
Measured: One-month post PGA Implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start26 May 2025
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Mak, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987890
- Sponsor's protocol ID
- 25-009
- Acronym
- Lung-GAP
- Status last verified
- Jun 2026
- First submitted
- 16 May 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Geriatric Assessment in Older Adults With Non-Small Cell Lung Cancer Undergoing Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT06987890
- Acronym / sponsor ID
- Lung-GAP / 25-009
- Keywords
- Lung Cancer, Geriatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Dec 2026 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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; namely, FaceAge, a validated deep learning model capable of estimating biological age from still facial images.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGA IMPLEMENTED IN NSCLC WITH SBRT | Experimental | Other: Practical Geriatric AssessmentProviders 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Practical Geriatric AssessmentAlso: PGAThe 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. | Other | PGA IMPLEMENTED IN NSCLC WITH SBRT |
Primary outcome
Rate of referral to recommended supportive care services
Time frame: One-month post PGA Implementation
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.
1 secondary outcome
Patient acceptance of PGA usage
Time frame: One-month post PGA Implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Practical Geriatric Assessment in people with Lung Cancer (NSCLC) and Geriatric Assessment, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of referral to recommended supportive care services (time frame: One-month post PGA Implementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.