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CompletedNCT03442452Updated Oct 15, 2019

AML Electronic Decision Aid

An interventional study of Electronic Decision Aid Tool in Acute Myeloid Leukemia, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients too sick to participate per clinician discretion
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Electronic Decision Aid

    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.

    Other: Electronic Decision Aid Tool

Interventions

  • OtherElectronic Decision Aid Tool

    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.

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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)

    Time frame: Day 1. Pre-video screening and post-video

Other outcomes

  1. Changes in Attitudes Towards Chemotherapy Scale scores

    Changes in Attitudes Towards Chemotherapy Scale scores,

    Time frame: Day 1. Pre-video screening and post-video

  2. Changes in Decisional Conflict Scale scores

    Changes in Decisional Conflict Scale scores

    Time frame: Day 1. Pre-video screening and post-video

  3. Changes in Anxiety Scores

    Changes in Anxiety Scores

    Time frame: Day 1. Pre-video screening and post-video

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03442452
Lead sponsor
Duke University
Collaborators
American Cancer Society, Inc.
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 7, 2018
Primary completion
Feb 1, 2019
Completion
Feb 1, 2019
Last update
Oct 15, 2019

Study contacts

Thomas LeBlanc
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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