Acute Myeloid Leukemia
Conditions
Brief summary
This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.
Detailed description
Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.
Interventions
BEHAVIORALBehavioral: UR-GOAL communication tool
The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Patients: * Age ≥60 years (conventional definition of older age in AML) * Newly diagnosed AML * Considering treatment * Able to provide informed consent * English-speaking Inclusion Criteria for Caregivers: * Selected by the patient when asked if there is a "family member, partner, friend or caregiver \[age 21 or older\] with whom you 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. * Able to provide informed consent * English-speaking Inclusion Criteria for Oncologists: * A practicing oncologist * At least one of their patients are recruited to the study * English-speaking
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility (Recruitment Rates) | Four weeks | Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment |
| Usefulness | Four weeks | Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) | Four weeks | A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks. |
| Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7 | Four weeks | A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks. |
| Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15 | Four Weeks | A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKah Poh Loh, MD
University of Rochester
Participant flow
Recruitment details
We recruited older patients with AML, their caregivers, and oncologists from the University of Rochester Medical Center Wilmot Cancer Institute (WCI) and its affiliated oncology practices in upstate New York. Participants were recruited between October 2021 and March 2022.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Experimental Arm: single The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.
Behavioral: UR-GOAL communication tool: The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Experimental: Experimental Arm: single |
|---|---|
| Age, Continuous | 76 years STANDARD_DEVIATION 80 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Feasibility (Recruitment Rates)
Percentage of patients who consented to the study ultimately completed the study intervention and post-intervention assessment
Time frame: Four weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental: Experimental Arm: single | Feasibility (Recruitment Rates) | 11 Participants |
Primary
Usefulness
Usefulness was assessed using the Preparation for Decision Making Scale (mean score range from 1 to 5, and higher scores indicate greater usefulness)
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Experimental Arm: single | Usefulness | 3.8 score on a scale | Standard Deviation 0.7 |
Secondary
Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7
A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms. Pre-post changes from baseline to four weeks.
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Experimental Arm: single | Pre-post Changes in the Following Outcomes: General Anxiety Disorder-7 | -1.6 score on a scale | Standard Deviation 5.4 |
Secondary
Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15
A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms. Pre-post changes from baseline to four weeks.
Time frame: Four Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Experimental Arm: single | Pre-post Changes in the Following Outcomes: Geriatric Depression Scale-15 | 0.2 score on a scale | Standard Deviation 2.1 |
Secondary
Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)
A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy. Pre-post changes from baseline to four weeks.
Time frame: Four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Experimental Arm: single | Pre-post Changes in the Following Outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) | 1.5 score on a scale | Standard Deviation 3 |