Clinical trial · Interventional
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
NCT06697600CI-TRIAL-00116864UR-GOAL RCTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Myeloid Leukemia, Acute | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UR-GOAL | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- UR-GOAL Intervention
- description
- 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.
- interventionNames
- Behavioral: UR-GOAL
- type
- NO_INTERVENTION
- label
- Attention Control Arm
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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 Exclusion criteria
References
Publications (1)
- BACKGROUNDLoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19. PMID 36533397