Metastatic Gastric CancerNCT04618809
Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
A study testing Didactic Session and Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status. in people with Metastatic Gastric Cancer, run by Fox Chase Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of the unique aspects of care required for older patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metastatic Gastric Cancer
- What is being tested?
- Didactic Session and Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.
- Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.
- Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.
- Life expectancy ≥3 months.
Who cannot join
- ≤69 years old.
- Inability to read and understand English.
- No evidence of mGC.
- Not on active therapy.
- Life expectancy <3 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Efrat Dotan, MD, 215-214-4283, Efrat.Dotan@fccc.edu
- Not yet recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Juhi Mittal, MD, 267-563-1580, Judi.mittal@tuhs.temple.edu
About this study
The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older mGC patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases.
Read the detailed description
Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age.
A significant challenge that surrounds the treatment of the older metastatic gastric cancer (mGC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges, a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy.
The purpose of this research study is to enhance the care of the older mGC patient by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic gastric cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases:
- Needs assessments - to understand the population of older gastric cancer patients seen in routine practice at community and academic centers, and assess their treatment approach.
- Educational programming about management of older metastatic gastric cancer patients, and geriatric assessment of these patients.
- Active testing of the use of geriatric assessment in clinical practice, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
- Short-term follow-up chart reviews (2-3 months post intervention) to assess for actual implementation of recommended interventions identified by the geriatric assessment.
The ultimate goal is to expand this educational intervention to other oncology practices beyond those participating in this study, and for all older cancer patients regardless of their disease site. During this study period we will identify the specific gaps that exist in each practice for the care of older patients with mGC. This information is crucial to understand the needs of this patient population and will inform future trials with possible intervention. The second phase of our study will expose the practices to the use of a geriatric assessment through a patient's self-assessment tool and demonstrate its feasibility. Our hope is that all involved practices will find benefit from incorporating a geriatric assessment into their practice and will continue to use it in the future.
- Conditions
- Metastatic Gastric Cancer
- Being tested
- Didactic Session, Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didactic SessionBehavioural
This session will include an overview of the approach to and management of older mGC patients patients through a case-based presentation.
Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.Behavioural
- The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.
- The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Provider Didactic Intervention | Experimental | * Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site.
* Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment.
* Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment. Receives: Behavioral: Didactic Session; Behavioral: Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.
The Comprehensive Geriatric Assessment includes the following scales:
Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale
Measured: 18 Months
Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
Measured: 18 months
Secondary outcomes (7)
Provider perception (Review of Geriatric Assessment Questionnaire)
Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire
Measured: 18 months
Fitbit assessed functional status. Fitbit data: step count
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between step count, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Fitbit assessed functional status. Fitbit data: distance logged
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between distance logged, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between moderately active, lightly active, and sedentary minute categorization, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Fitbit assessed functional status. Fitbit data: floors climbed
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between floors climbed, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Fitbit assessed functional status. Fitbit data: calories burned
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between calories burned, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Fitbit assessed functional status. Fitbit data: heart rate
We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between heart rate, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.
We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Eli Lilly and Company
- Responsible party
- Principal investigator, Efrat Dotan, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618809
- Sponsor's protocol ID
- 20-8006
- Status last verified
- Feb 2023
- First submitted
- 2 Nov 2020
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT04618809
- Acronym / sponsor ID
- 20-8006
- Conditions
- Metastatic Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, Eli Lilly and Company
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Nov 2020 (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.
The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older mGC patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases.
Detailed description
Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age.
A significant challenge that surrounds the treatment of the older metastatic gastric cancer (mGC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges, a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy.
The purpose of this research study is to enhance the care of the older mGC patient by increasing awareness among oncology providers of the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic gastric cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases:
- Needs assessments - to understand the population of older gastric cancer patients seen in routine practice at community and academic centers, and assess their treatment approach.
- Educational programming about management of older metastatic gastric cancer patients, and geriatric assessment of these patients.
- Active testing of the use of geriatric assessment in clinical practice, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.
- Short-term follow-up chart reviews (2-3 months post intervention) to assess for actual implementation of recommended interventions identified by the geriatric assessment.
The ultimate goal is to expand this educational intervention to other oncology practices beyond those participating in this study, and for all older cancer patients regardless of their disease site. During this study period we will identify the specific gaps that exist in each practice for the care of older patients with mGC. This information is crucial to understand the needs of this patient population and will inform future trials with possible intervention. The second phase of our study will expose the practices to the use of a geriatric assessment through a patient's self-assessment tool and demonstrate its feasibility. Our hope is that all involved practices will find benefit from incorporating a geriatric assessment into their practice and will continue to use it in the future.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Provider Didactic Intervention | Experimental | Behavioral: Didactic Session, Behavioral: Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.* Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site. * Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment. * Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.
- Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.
- Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.
- Life expectancy ≥3 months.
Key exclusion criteria (5 listed)
- ≤69 years old.
- Inability to read and understand English.
- No evidence of mGC.
- Not on active therapy.
- Life expectancy <3 months.
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 |
|---|---|---|
| Didactic SessionThis session will include an overview of the approach to and management of older mGC patients patients through a case-based presentation. | Behavioural | Provider Didactic Intervention |
| Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.* The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy. * The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded. | Behavioural | Provider Didactic Intervention |
Primary outcome
Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)
Time frame: 18 Months
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%. The Comprehensive Geriatric Assessment includes the following scales: Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale
Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)
Time frame: 18 months
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
7 secondary outcomes
Provider perception (Review of Geriatric Assessment Questionnaire)
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: step count
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: distance logged
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: floors climbed
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: calories burned
Time frame: 18 months
Fitbit assessed functional status. Fitbit data: heart rate
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didactic Session and Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status. in people with Metastatic Gastric Cancer, run by Fox Chase Cancer Center at 2 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrat Dotan, MD (215-214-4283, Efrat.Dotan@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment) (time frame: 18 Months). The study lists 2 primary outcomes in all. 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 15 Feb 2023.