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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

Tracking Information
First Submitted Date  ICMJE February 2, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE February 7, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03442452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2018)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2018)
  • Changes in Attitudes Towards Chemotherapy Scale scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Attitudes Towards Chemotherapy Scale scores,
  • Changes in Decisional Conflict Scale scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Decisional Conflict Scale scores
  • Changes in Anxiety Scores [ Time Frame: Day 1. Pre-video screening and post-video ]
    Changes in Anxiety Scores
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE AML Electronic Decision Aid
Official Title  ICMJE A Pilot Feasibility and Preliminary Efficacy Study of an Electronic Decision Aid for Patients With Acute Myeloid Leukemia (AML)
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Acute Myeloid Leukemia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Electronic Decision Aid Tool
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03442452
Other Study ID Numbers  ICMJE Pro00091220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE American Cancer Society, Inc.
Investigators  ICMJE
Principal Investigator: Thomas LeBlanc Duke University
PRS Account Duke University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP