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AML Electronic Decision Aid

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Decision Aid Tool
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • Patients too sick to participate per clinician discretion

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Electronic Decision Aid

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
February 2, 2018
Last Updated
October 11, 2019
Sponsor
Duke University
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03442452
Brief Title
AML Electronic Decision Aid
Official Title
A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
American Cancer Society, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Decision Aid
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electronic Decision Aid Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of enrolled subjects who have completed the study
Description
Feasibility will be determined by enrolled subjects who complete the study (including watching all videos, and completing the surveys).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Change in knowledge about AML after video viewing
Description
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 Pre-specified Outcome Measures:
Title
Changes in Attitudes Towards Chemotherapy Scale scores
Description
Changes in Attitudes Towards Chemotherapy Scale scores,
Time Frame
Day 1. Pre-video screening and post-video
Title
Changes in Decisional Conflict Scale scores
Description
Changes in Decisional Conflict Scale scores
Time Frame
Day 1. Pre-video screening and post-video
Title
Changes in Anxiety Scores
Description
Changes in Anxiety Scores
Time Frame
Day 1. Pre-video screening and post-video

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Patients too sick to participate per clinician discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas LeBlanc
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33159220
Citation
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.
Results Reference
derived

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AML Electronic Decision Aid

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