Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Brief summary
This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Detailed description
Older adults with AML and MDS are more likely to receive aggressive care and less likely to utilize hospice at the end-of-life. Advance care planning (ACP) intervention delivered through telehealth may improve patient-reported outcomes and end-of-life care in this population. This pilot study seeks to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention. We will adapt the Serious Illness Care Program.
Interventions
BEHAVIORALTelehealth
Telehealth ACP intervention advance care planning intervention
BEHAVIORALControl
For the control arm, no telehealth visit will be scheduled.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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/MDS) * AML or MDS diagnosis * Being managed in the outpatient settings * Able to provide informed consent * English-speaking
Exclusion criteria
N/A Inclusion Criteria for Caregivers * Age ≥21 years * Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters" * Able to provide informed consent * English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Retention Rate | 12 Weeks | Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components |
| Recruitment Rate | 12 Weeks | Number of patients, caregivers, and clinicians who are approached and agree to enroll. |
| Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) | 12 Weeks | Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) | 12 Weeks | General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms) |
| Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) | 12 Weeks | Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms). |
| Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer | 12 Weeks | Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level). |
| Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | 12 Weeks | Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life). |
| Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) | 12 weeks | Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKah Poh Loh
Univ. of Rochester Wilmot Cancer Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Telehealth: Telehealth ACP intervention, advance care planning intervention
For the control group, no telehealth visits were scheduled. | 20 |
| Caregiver The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Telehealth: Telehealth ACP intervention, advance care planning intervention
For the control group, no telehealth visits were scheduled. | 6 |
| Clinician The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Telehealth: Telehealth ACP intervention, advance care planning intervention
For the control group, no telehealth visits were scheduled. | 9 |
| Total | 35 |
Baseline characteristics
| Characteristic | Patient | Caregiver | Clinician | Total |
|---|---|---|---|---|
| Age, Continuous Patient | 75 years STANDARD_DEVIATION 5.9 | 64 years STANDARD_DEVIATION 13.7 | 44 years STANDARD_DEVIATION 11.7 | 65.1 years STANDARD_DEVIATION 16.1 |
| Ethnicity (NIH/OMB) Patient Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Patient Not Hispanic or Latino | 16 Participants | 5 Participants | 9 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Patient Unknown or Not Reported | 4 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Patient American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Patient Black or African American | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Patient More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Patient White | 17 Participants | 6 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Patient Female | 9 Participants | 4 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Patient Male | 11 Participants | 2 Participants | 3 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 0 / 6 | 0 / 10 |
| other Total, other adverse events | 0 / 20 | 0 / 6 | 0 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 6 | 0 / 10 |
Outcome results
Primary
Feasibility - Retention Rate
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
Time frame: 12 Weeks
Population: Retention rate was focused for the patient and caregiver populations.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Feasibility - Retention Rate | 19 Participants |
| Caregiver | Feasibility - Retention Rate | 6 Participants |
| Clinician | Feasibility - Retention Rate | 10 Participants |
Primary
Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)
Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7, a higher score indicates greater usability) assessing the usability of telehealth implementation across the population (for patients or caregivers), the mean of all questions is then calculated, range 1-7, with an average of greater than 5 considered usable.
Time frame: 12 Weeks
Population: Usability was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers answered the survey. The clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) | 5.9 score on a scale | Standard Deviation 0.9 |
| Caregiver | Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) | 5.9 score on a scale | Standard Deviation 1.1 |
Primary
Recruitment Rate
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
Time frame: 12 Weeks
Population: There are 29 patients analyzed because that many were approached, then 21 consented. One patient consented but withdrew before the intervention was initiated, leaving 20 enrolled participants. There were 7 caregivers approached, but 1 caregiver withdrew due to medical reasons. All 10 clinicians approached consented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient | Recruitment Rate | 21 Participants |
| Caregiver | Recruitment Rate | 6 Participants |
| Clinician | Recruitment Rate | 10 Participants |
Secondary
Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' satisfaction with patient-oncologist communication (12 items, range from 12-60), higher score indicates greater satisfaction with communication.
Time frame: 12 weeks
Population: Health Care Communication Questionnaire was an optional assessment, and 2 participants opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) | 18.3 score on a scale | Standard Deviation 2.1 |
| Caregiver | Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) | 18.2 score on a scale | Standard Deviation 2.9 |
Secondary
Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level).
Time frame: 12 Weeks
Population: Distress Thermometer was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer | 0.3 score on a scale | Standard Deviation 2.4 |
| Caregiver | Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer | -1.3 score on a scale | Standard Deviation 1.4 |
Secondary
Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life).
Time frame: 12 Weeks
Population: Functional Assessment of Cancer Therapy-Leukemia was an optional assessment, and 2 patients opted not to complete the survey. Therefore, data was not collected. The caregivers and clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | -3.3 score on a scale | Standard Deviation 17.6 |
Secondary
Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)
General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)
Time frame: 12 Weeks
Population: General Anxiety Disorder-7 was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) | 0.1 score on a scale | Standard Deviation 2.2 |
| Caregiver | Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) | -2.8 score on a scale | Standard Deviation 5 |
Secondary
Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms).
Time frame: 12 Weeks
Population: Patient Health Questionnaire-9 was an optional assessment, and 3 patients opted not to complete the survey. Therefore, data was not collected. All caregivers completed the survey. The clinicians were not included in the population of this aim.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient | Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) | 0.4 score on a scale | Standard Deviation 4.2 |
| Caregiver | Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) | -1.0 score on a scale | Standard Deviation 3 |