AML Electronic Decision Aid

NCT03442452 | Completed

• 1 other identifier: Pro00091220
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in knowledge about AML after video viewing

  Day 1. Pre-video screening and post-video

Other Outcomes (3)

• Changes in Attitudes Towards Chemotherapy Scale scores

  Day 1. Pre-video screening and post-video

• Changes in Decisional Conflict Scale scores

  Day 1. Pre-video screening and post-video

• Changes in Anxiety Scores

  Day 1. Pre-video screening and post-video

Study Arms (1)

Electronic Decision Aid

OTHER

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

Interventions

Electronic Decision Aid Tool OTHER

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.

Electronic Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients too sick to participate per clinician discretion

Sponsors & Collaborators

• Duke University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 33159220 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thomas LeBlanc

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 22, 2018
• Study Start: February 7, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)