Clinical trial NCT03442452: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2018-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Number of enrolled subjects who have completed the study
timeFrame: 1 day
Secondary outcomes:
measure: Change in knowledge about AML after video viewing
timeFrame: Day 1. Pre-video screening and post-video
Other outcomes:
measure: Changes in Attitudes Towards Chemotherapy Scale scores
timeFrame: Day 1. Pre-video screening and post-video
measure: Changes in Decisional Conflict Scale scores
timeFrame: Day 1. Pre-video screening and post-video
measure: Changes in Anxiety Scores
timeFrame: Day 1. Pre-video screening and post-video
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas LeBlanc
role: PRINCIPAL_INVESTIGATOR
References:
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.