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AML Electronic Decision Aid

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ClinicalTrials.gov Identifier: NCT03442452
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Electronic Decision Aid Tool Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
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
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 Measures :
  1. 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).


Secondary Outcome Measures :
  1. Change in knowledge about AML after video viewing [ Time Frame: Day 1. Pre-video screening and post-video ]
    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)


Other Outcome Measures:
  1. Changes in Attitudes Towards Chemotherapy Scale scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Attitudes Towards Chemotherapy Scale scores,

  2. Changes in Decisional Conflict Scale scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Decisional Conflict Scale scores

  3. Changes in Anxiety Scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Anxiety Scores



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442452


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
American Cancer Society, Inc.
Investigators
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Principal Investigator: Thomas LeBlanc Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03442452     History of Changes
Other Study ID Numbers: Pro00091220
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms