A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
Purpose
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.
Conditions
- Oncology
- Myeloid Leukemia, Acute
- Cancer
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥60 years (from date of consent, confirmed on electronic medical records) - A new diagnosis of AML - Diagnosis can be based on the International Consensus Classification or World Health Organization - Myeloid sarcoma is allowed - AML with central nervous system involvement is allowed - Cancer-directed treatment has not started - Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine - Intrathecal chemotherapy is acceptable - The patient's oncologist has been or will be enrolled on the study - English or Spanish-speaking - Patients without a caregiver will still be eligible to participate in the study
Exclusion Criteria
- A diagnosis of acute promyelocytic leukemia - Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures - Prior cancer-directed treatment for AML Caregivers Inclusion criteria: - Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 18 or older] with whom you discuss or who can be helpful in healthrelated matters." - Caregiver may be paid/professional or informal caregiver - Able to provide informed consent - English or Spanish-speaking Oncologists Inclusion criteria: • Oncologists caring for patients with AML Exclusion criteria
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be randomized 1:1 to either the UR-GOAL arm or the attention control arm. If the patient has a caregiver that agrees and consents to participate in the study, the caregiver will be enrolled onto the same arm as the patient.
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental UR-GOAL Intervention |
Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits. |
|
|
No Intervention Attention Control Arm |
Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits. |
|
Recruiting Locations
University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- University of Rochester
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.