AML Electronic Decision Aid

Acute Myeloid Leukemia Clinical Trial

Official title:

A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442452
• Other study ID #: Pro00091220
• Status: Completed
• Phase: N/A
• Start date: February 7, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Electronic 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Attitudes Towards Chemotherapy Scale scores	Changes in Attitudes Towards Chemotherapy Scale scores,	Day 1. Pre-video screening and post-video
Other	Changes in Decisional Conflict Scale scores	Changes in Decisional Conflict Scale scores	Day 1. Pre-video screening and post-video
Other	Changes in Anxiety Scores	Changes in Anxiety Scores	Day 1. Pre-video screening and post-video
Primary	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).	1 day
Secondary	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)	Day 1. Pre-video screening and post-video