Acute Myeloid LeukemiaNCT03442452
AML Electronic Decision Aid
A study testing Electronic Decision Aid Tool in people with Acute Myeloid Leukemia, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the feasibility and preliminary efficacy of a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Electronic Decision Aid Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 1 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least age 18
- Capacity to give consent
- Diagnosis of acute myeloid leukemia (AML)
- Fluent in English
- Receiving care at Duke, and fits into one of the following scenarios:
- has not yet made a treatment decision (in the DCI clinics or on the inpatient wards),
- have recently made a decision (in the last 6 weeks), and are admitted for chemotherapy on 9100 or in the oncology treatment center to receive outpatient therapy,
- or, during remission, while receiving consolidation chemotherapy in the hospital
Who cannot join
- Patients too sick to participate per clinician discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)
The purpose of this study is to test the feasibility and preliminary efficacy of a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options.
Read the detailed description
The purpose of this study is to test the feasibility and preliminary efficacy of a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options. The objective of our program of research is to ultimately improve understanding about what patients with Acute Myeloid Leukemia (AML) know and understand about their disease, as well as what kind of information AML patients want or need to further inform them about the treatment decisions they face.
The AML Decision Aid tool consists of ten video modules, approximately 3 minutes each, containing content regarding key areas such as an explanation of what AML is, treatment choices, and things to consider when determining a treatment path. Recruited subjects will complete a series of surveys, both before viewing of the videos and after
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Electronic Decision Aid Tool
- 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.
Electronic Decision Aid ToolOther
The AML Decision Aid tool consists of ten video modules, approximately 3 minutes each, containing content regarding key areas such as an explanation of what AML is, treatment choices, and things to consider when determining a treatment path.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Decision Aid | Other | For this study, we will be testing a novel electronic decision aid to improve Acute Myeloid Leukemia patients' understanding of their illness, prognosis, and treatment options. Receives: Other: Electronic Decision Aid Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of enrolled subjects who have completed the study
Feasibility will be determined by enrolled subjects who complete the study (including watching all videos, and completing the surveys).
Measured: 1 day
Secondary outcomes (1)
Change in knowledge about AML after video viewing
Efficacy will be measured by change in knowledge about AML, (including knowledge about the disease itself, and comprehending AML treatment choices and their risks, as measured through changes in AML Knowledge Questionnaire scores)
Measured: Day 1. Pre-video screening and post-video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start7 Feb 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- For this study, we will test the feasibility and preliminary efficacy of utilizing a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas LeBlanc, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442452
- Sponsor's protocol ID
- Pro00091220
- Status last verified
- Mar 2019
- First submitted
- 2 Feb 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hildenbrand JD, Davis DM, El-Jawahri A, Herring KW, Locke SC, Pollak KI, Samsa GP, Steinhauser KE, Troy JD, Ubel PA, Leblanc TW. A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial. Support Care Cancer. 2021 Jul;29(7):3563-3569. doi: 10.1007/s00520-020-05864-5. Epub 2020 Nov 6.
PubMed 33159220
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT03442452
- Acronym / sponsor ID
- Pro00091220
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 Feb 2018 (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 test the feasibility and preliminary efficacy of a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options.
Detailed description
The purpose of this study is to test the feasibility and preliminary efficacy of a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options. The objective of our program of research is to ultimately improve understanding about what patients with Acute Myeloid Leukemia (AML) know and understand about their disease, as well as what kind of information AML patients want or need to further inform them about the treatment decisions they face.
The AML Decision Aid tool consists of ten video modules, approximately 3 minutes each, containing content regarding key areas such as an explanation of what AML is, treatment choices, and things to consider when determining a treatment path. Recruited subjects will complete a series of surveys, both before viewing of the videos and after
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For this study, we will test the feasibility and preliminary efficacy of utilizing a novel electronic decision aid to improve AML patients' understanding of their illness, prognosis, and treatment options.
| Arm | Type | Receives |
|---|---|---|
| Electronic Decision Aid | Other | Other: Electronic Decision Aid ToolFor this study, we will be testing a novel electronic decision aid to improve Acute Myeloid Leukemia patients' understanding of their illness, prognosis, and treatment options. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least age 18
- Capacity to give consent
- Diagnosis of acute myeloid leukemia (AML)
- Fluent in English
- Receiving care at Duke, and fits into one of the following scenarios:
Key exclusion criteria (1 listed)
- Patients too sick to participate per clinician discretion
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 |
|---|---|---|
| Electronic Decision Aid ToolThe AML Decision Aid tool consists of ten video modules, approximately 3 minutes each, containing content regarding key areas such as an explanation of what AML is, treatment choices, and things to consider when determining a treatment path. | Other | Electronic Decision Aid |
Primary outcome
Number of enrolled subjects who have completed the study
Time frame: 1 day
Feasibility will be determined by enrolled subjects who complete the study (including watching all videos, and completing the surveys).
1 secondary outcome
Change in knowledge about AML after video viewing
Time frame: Day 1. Pre-video screening and post-video
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 15 Oct 2019.
- Derived from this study: PubMed 33159220Hildenbrand JD, Davis DM, El-Jawahri A, Herring KW, Locke SC, Pollak KI, Samsa GP, Steinhauser KE, Troy JD, Ubel PA, Leblanc TW. A novel decision aid for acute myeloid leukemia: a feasibility and preliminary efficacy trial. Support Care Cancer. 2021 Jul;29(7):3563-3569. doi: 10.1007/s00520-020-05864-5. Epub 2020 Nov 6.
- 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.
Thomas LeBlanc principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Decision Aid Tool in people with Acute Myeloid Leukemia, run by Duke University 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 8 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: finished, as of the sponsor's last update on 15 Oct 2019. 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?
Number of enrolled subjects who have completed the study (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03442452, which also lists 1 linked publication.
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 Oct 2019.