A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers

Not Applicable

Not yet recruiting

• Conditions: Oncology; Myeloid Leukemia, Acute; Cancer

• Registration Number: NCT06697600
• Lead Sponsor: University of Rochester

Brief Summary

This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control.

Detailed Description

This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention \[University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)\] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.

Study Timeline

• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03
• Study Start: 2025-06-01
• Primary Completion: 2028-06-01
• Study Completion: 2030-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Distress Thermometer Questionnaire at 1 month	1 month	A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.

Secondary Outcome Measures

Name	Time	Method
9-item Shared Decision Making Questionnaire at 2 weeks	2 weeks	9-item Shared Decision Making Questionnaire at 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks	2 weeks	Decisional Conflict Scale Questionnaire at 2 weeks
Observed shared decision making	Day 0	OPTION5 instrument from audio-recorded treatment decision-making clinical visits

Trial Locations

Locations (3)

University of Alabama at Birmingham, Division of Hematology and Oncology; 🇺🇸 Birmingham, Alabama, United States

University of North Carolina Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology; 🇺🇸 Winston-Salem, North Carolina, United States