A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- University of Rochester
- Enrollment
- 1020
- Locations
- 4
- Primary Endpoint
- Distress Thermometer Questionnaire at 1 month
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Kah Poh Loh
Associate Professor, Division of Hematology/Oncology, Department of Medicine
University of Rochester
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Distress Thermometer Questionnaire at 1 month
Time Frame: 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 Outcomes
- 9-item Shared Decision Making Questionnaire at 2 weeks(2 weeks)
- Decisional Conflict Scale Questionnaire at 2 weeks(2 weeks)
- Observed shared decision making(Day 0)