Acute Myeloid LeukemiaNCT04158726
Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
A study testing modified Geriatric Assessment (mGA) in people with Acute Myeloid Leukemia, run by Carevive Systems, Inc. at 1 site in United States.
Trial summary
Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- modified Geriatric Assessment (mGA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 31 Dec 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must be adults ages 18 years of age or older.
- Patient participants must have a diagnosis of AML.
- Patients may be newly diagnosed, needing a new line of therapy and have not yet made a treatment decision, or on treatment and being assessed for potential new treatment
- All participants must be able to understand English.
Who cannot join
- Any patient who cannot understand written or spoken English.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham
Birmingham, Alabama, 35233
About this study
Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.
Read the detailed description
This outcomes study has a two-part intervention that includes 1) provider education and 2) patient and provider use of Carevive Treatment Care Planning technology. The provider education component of the intervention highlights evidenced guidelines and investigational agents in the treatment of AML in older adults. The Carevive CPS will be used for the second component of the intervention. The results of this study will provide important information about drivers of treatment decision-making and practice patterns, feasibility of a technology platform to incorporate important, but under-utilized components of value-based care into practice, and healthcare utilization data.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- modified Geriatric Assessment (mGA)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Geriatric Assessment (mGA)Behavioural
The mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
Clinical outcomes include time on treatment, adherence to the prescribed treatment, quality of life (QoL), and patient side effects. Providers will review results of the mGA at a treatment decision visit and indicate if the mGA results influenced the treatment selection. Chart abstraction will be conducted at a 3-month post treatment planning visit time point to confirm treatment given. Baseline and 3-month QoL and symptom assessment measures will be collected and change over time will be analyzed. Comparisons of change in QoL and symptoms over 3 months, total time on treatment, and adherence among fit, intermediate, and frail groups will be made.
Measured: 3 months
Secondary outcomes (1)
Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),
Quantitative measures include data collected by the Carevive CPS platform to describe treatment practice patterns of hematologists caring for older patients with AML at three study sites. At baseline, and then again as part of participating clinicians' exit interview, each clinician will complete a survey that asks about his/her behaviors related to assessment and management of their older AML patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start26 Apr 2019
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carevive Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debbie Wujcik, PhD,RN, Principal investigator, Carevive Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158726
- Sponsor's protocol ID
- 422 AML GA
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2019
- Last updated
- 18 Jan 2022
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Geriatric Assessment for Older Patients Diagnosed With Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT04158726
- Acronym / sponsor ID
- 422 AML GA
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Carevive Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 12 Nov 2019 (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.
Despite the suggestions that GA and frailty indices could be used to guide therapy selection, the ability to effectively incorporate the use of GA in older patients diagnosed with AML in a real-world clinic environment has not yet been established. Thus, in this study, the investigators seek to describe the feasibility of using this shorter GA tool, the mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.
Detailed description
This outcomes study has a two-part intervention that includes 1) provider education and 2) patient and provider use of Carevive Treatment Care Planning technology. The provider education component of the intervention highlights evidenced guidelines and investigational agents in the treatment of AML in older adults. The Carevive CPS will be used for the second component of the intervention. The results of this study will provide important information about drivers of treatment decision-making and practice patterns, feasibility of a technology platform to incorporate important, but under-utilized components of value-based care into practice, and healthcare utilization data.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All participants must be adults ages 18 years of age or older.
- Patient participants must have a diagnosis of AML.
- Patients may be newly diagnosed, needing a new line of therapy and have not yet made a treatment decision, or on treatment and being assessed for potential new treatment
- All participants must be able to understand English.
Key exclusion criteria (2 listed)
- Any patient who cannot understand written or spoken English.
- Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
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 |
|---|---|---|
| modified Geriatric Assessment (mGA)The mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making. | Behavioural | – |
Primary outcome
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making.
Time frame: 3 months
Clinical outcomes include time on treatment, adherence to the prescribed treatment, quality of life (QoL), and patient side effects. Providers will review results of the mGA at a treatment decision visit and indicate if the mGA results influenced the treatment selection. Chart abstraction will be conducted at a 3-month post treatment planning visit time point to confirm treatment given. Baseline and 3-month QoL and symptom assessment measures will be collected and change over time will be analyzed. Comparisons of change in QoL and symptoms over 3 months, total time on treatment, and adherence among fit, intermediate, and frail groups will be made.
1 secondary outcome
Review of Real-world clinician practice patterns of hematologists managing older patients with AML (age>60),
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- 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. This study is not recruiting at the moment.
Debbie Wujcik, PhD,RN principal investigator
Carevive Systems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Geriatric Assessment (mGA) in people with Acute Myeloid Leukemia, run by Carevive Systems, Inc. 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation of mGA for patients with AML on clinical outcomes at three months post treatment decision making. (time frame: 3 months). 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 18 Jan 2022.