Trial Outcomes & Findings for A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (NCT NCT04745676)
NCT ID: NCT04745676
Last Updated: 2026-01-21
Results Overview
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
12 Weeks
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
10
|
|
Overall Study
COMPLETED
|
19
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
20 patients were included in the population of the study.
Baseline characteristics by cohort
| Measure |
Patient
n=20 Participants
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.
|
Caregiver
n=6 Participants
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.
|
Clinician
n=9 Participants
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.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Patient
|
75 years
STANDARD_DEVIATION 5.9 • n=37 Participants
|
64 years
STANDARD_DEVIATION 13.7 • n=44 Participants
|
44 years
STANDARD_DEVIATION 11.7 • n=40 Participants
|
65.1 years
STANDARD_DEVIATION 16.1 • n=121 Participants
|
|
Sex: Female, Male
Patient · Female
|
9 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
6 Participants
n=40 Participants
|
19 Participants
n=121 Participants
|
|
Sex: Female, Male
Patient · Male
|
11 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
16 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Patient · Hispanic or Latino
|
0 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Ethnicity (NIH/OMB)
Patient · Not Hispanic or Latino
|
16 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
5 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
9 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
30 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Ethnicity (NIH/OMB)
Patient · Unknown or Not Reported
|
4 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
1 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
5 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · American Indian or Alaska Native
|
0 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · Asian
|
0 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
1 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
1 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · Black or African American
|
1 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
1 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · White
|
17 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
6 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
8 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
31 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · More than one race
|
0 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
|
Race (NIH/OMB)
Patient · Unknown or Not Reported
|
2 Participants
n=37 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=44 Participants • 20 patients were included in the population of the study.
|
0 Participants
n=40 Participants • 20 patients were included in the population of the study.
|
2 Participants
n=121 Participants • 20 patients were included in the population of the study.
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Retention rate was focused for the patient and caregiver populations.
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
Outcome measures
| Measure |
Patient
n=20 Participants
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.
|
Caregiver
n=6 Participants
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.
|
Clinician
n=10 Participants
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.
|
|---|---|---|---|
|
Feasibility - Retention Rate
|
19 Participants
|
6 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 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.
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
Outcome measures
| Measure |
Patient
n=29 Participants
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.
|
Caregiver
n=7 Participants
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.
|
Clinician
n=10 Participants
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.
|
|---|---|---|---|
|
Recruitment Rate
|
21 Participants
|
6 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Patient
n=17 Participants
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.
|
Caregiver
n=6 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
5.9 score on a scale
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)
Outcome measures
| Measure |
Patient
n=17 Participants
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.
|
Caregiver
n=6 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
-2.8 score on a scale
Standard Deviation 5.0
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
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).
Outcome measures
| Measure |
Patient
n=17 Participants
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.
|
Caregiver
n=6 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
-1.0 score on a scale
Standard Deviation 3.0
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level).
Outcome measures
| Measure |
Patient
n=17 Participants
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.
|
Caregiver
n=6 Participants
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.
|
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.
|
|---|---|---|---|
|
Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
|
0.3 score on a scale
Standard Deviation 2.4
|
-1.3 score on a scale
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 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.
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).
Outcome measures
| Measure |
Patient
n=18 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
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 outcome
Timeframe: 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Patient
n=18 Participants
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.
|
Caregiver
n=6 Participants
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.
|
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.
|
|---|---|---|---|
|
Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
|
18.3 score on a scale
Standard Deviation 2.1
|
18.2 score on a scale
Standard Deviation 2.9
|
—
|
Adverse Events
Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinicians
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Project Manager
University of Rochester Medical Center, Wilmot Cancer Institute
Phone: 585 410 5044
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place