Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, communication, shared decision making, older adults, geriatric hematology
Brief summary
The objective of this study is to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision making and communication between older patients with AML and their oncologists in a pilot randomized trial.
Detailed description
The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.
Interventions
BEHAVIORALUR-GOAL
UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The UR-GOAL 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 1. Age ≥60 years 2. Newly diagnosed AML or being worked up for possible AML 3. Able to provide informed consent 4. Agreement of their oncologist to participate in the study 5. English-speaking If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist Caregivers 1. Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient 2. Able to provide informed consent 3. English-speaking Oncologists 1. A practicing oncologist 2. At least one of their patients are recruited to the study 3. English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making | Within 1-4 weeks after treatment initiation | A 9-item Shared Decision Making questionnaire (SDM-Q-9) assessing patient satisfaction with the medical decision-making process. Scores are transformed to a 0-100 scale in accordance with measure guidelines, with higher scores indicating greater shared decision making between the patient and the provider. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Centered Communication in Cancer Care (PCC-Ca-36) | Within 1-4 weeks after treatment initiation | A 36-item questionnaire assessing patient-centered communication in six domains: exchanging information, making decisions, fostering healing relationships, enabling patient self-management, managing uncertainty, and responding to emotions. The overall score and scores in each domain range from 1-5, higher scores indicate better communication. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKah Poh Loh
University of Rochester
Participant flow
Recruitment details
Patients aged 60 and above with AML were recruited from June 2022 to July 2025. Patients were recruited from 1) the Wilmot Cancer Institute inpatient malignant hematology service and 2) hematology clinics at Wilmot Cancer Institute. Enrolled patients could enroll with a caregiver, but were not required to. Oncologists at the Wilmot Cancer Institute were eligible if they treated at least one enrolled patient.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 73.9 Years STANDARD_DEVIATION 6.1 |
| ECOG (KPS) 0 (90-100) | 10 Participants |
| ECOG (KPS) 1 (70-80) | 47 Participants |
| ECOG (KPS) 2 (50-60) | 21 Participants |
| ECOG (KPS) 3 (30-40) | 6 Participants |
| Education College or Post-Graduate | 19 Participants |
| Education High School or Below | 0 Participants |
| Education Some College/University | 14 Participants |
| Employment Employed | 0 Participants |
| Employment Other | 0 Participants |
| Employment Retired, Unemployed, Homemaker | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| GDS-15 Impaired | 11 Participants |
| GDS-15 Missing | 1 Participants |
| GDS-15 Not Impaired | 0 Participants |
| Marital Status Divorced, Single, or Widowed | 48 Participants |
| Marital Status Married or Long-term partner | 105 Participants |
| Mini-Cog Impaired | 4 Participants |
| Mini-Cog Missing | 3 Participants |
| Mini-Cog Not Impaired | 84 Participants |
| Nutrition Impaired | 0 Participants |
| Nutrition Not Impaired | 42 Participants |
| Physical Function Impaired | 37 Participants |
| Physical Function Missing | 3 Participants |
| Physical Function Not Impaired | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 151 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 12 / 50 | 10 / 50 | 0 / 25 | 0 / 28 | 0 / 8 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 25 | 0 / 28 | 0 / 8 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 25 | 0 / 28 | 0 / 8 |
Outcome results
None listed