Cancer, Myeloid Leukemia, Acute, Oncology
Conditions
Keywords
older adults, geriatric oncology, caregivers
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.
Interventions
BEHAVIORALUR-GOAL
Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTKah Poh Loh
CONTACTBecky Gravenstede
Outcome results
None listed