Acute Myeloid LeukemiaSICGNCT04745676

A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

A study testing Telehealth in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Acute Myeloid Leukemia, Myelodysplastic Syndromes
What is being tested?: Telehealth
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 25 Mar 2021to 12 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Age ≥21 years

Show all 9Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester
Rochester, New York, 14642

Other trials in United States

About this study

Read the 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.

Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes
Being tested: Telehealth, Control
Keywords: Acute Myeloid Leukemia, Myelodysplastic Syndromes
Medical subject headings: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelehealthBehavioural
Telehealth ACP intervention advance care planning intervention
ControlBehavioural
For the control arm, no telehealth visit will be scheduled.

Study groups in NCT04745676
Study group	Role	What they receive
Patient	Experimental	The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Receives: Behavioral: Telehealth; Behavioral: Control
Caregiver	Experimental	The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Receives: Behavioral: Telehealth; Behavioral: Control
Oncology and Palliative Provider	Experimental	The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations. Receives: Behavioral: Telehealth; Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility - Retention Rate
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
Measured: 12 Weeks
Recruitment Rate
Number of patients, caregivers, and clinicians who are approached and agree to enroll.
Measured: 12 Weeks
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.
Measured: 12 Weeks

Secondary outcomes (5)

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)
Measured: 12 Weeks
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).
Measured: 12 Weeks
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).
Measured: 12 Weeks
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).
Measured: 12 Weeks
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Mar 202112 Jul 2023

First posted9 Feb 2021
Study start25 Mar 2021
Primary completion1 Mar 2023
Study completion12 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04745676
Sponsor's protocol ID: UCCO20134
Acronym: SICG
Status last verified: Mar 2026
First submitted: 4 Feb 2021
Last updated: 31 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.

Publications

LoCastro M, Wang Y, Yu T, Mortaz-Hedjri S, Mendler J, Norton S, Bernacki R, Carroll T, Klepin H, Wedow L, Goonan S, Erdos H, Bagnato B, Liesveld J, Huselton E, Kluger B, Loh KP. Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study. JMIR Form Res. 2024 Jun 27;8:e58503. doi: 10.2196/58503.
PubMed 38935428
LoCastro M, Mortaz-Hedjri S, Wang Y, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Liesveld J, Huselton E, Kluger B, Loh KP. Telehealth serious illness care program for older adults with hematologic malignancies: a single-arm pilot study. Blood Adv. 2023 Dec 26;7(24):7597-7607. doi: 10.1182/bloodadvances.2023011046.
PubMed 38088668
LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996.
PubMed 36521100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

All Acute Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT04745676
Acronym / sponsor ID: SICG / UCCO20134
Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes
Keywords: Acute Myeloid Leukemia, Myelodysplastic Syndromes
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 25 Mar 2021 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 9 Feb 2021 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Patient	Experimental	Behavioral: Telehealth, Behavioral: ControlThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Caregiver	Experimental	Behavioral: Telehealth, Behavioral: ControlThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Oncology and Palliative Provider	Experimental	Behavioral: Telehealth, Behavioral: ControlThe SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TelehealthTelehealth ACP intervention advance care planning intervention	Behavioural	Caregiver, Oncology and Palliative Provider, Patient
ControlFor the control arm, no telehealth visit will be scheduled.	Behavioural	Caregiver, Oncology and Palliative Provider, Patient

Primary outcome

Feasibility - Retention Rate
Time frame: 12 Weeks
Percentage of patients, caregivers, and clinicians who consented to the study, ultimately completing all study components
Recruitment Rate
Time frame: 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)
Time frame: 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.

5 secondary outcomes

Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)
Time frame: 12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
Time frame: 12 Weeks
Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Time frame: 12 Weeks
Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient	20	19
Caregiver	6	6
Clinician	10	10

Primary outcome: Feasibility - Retention Rate

Time frame: 12 Weeks. Count of participants. Unit: Participants

Measure	Patient n = 20	Caregiver n = 6	Clinician n = 10
Value	19	6	10

Population analysed: Retention rate was focused for the patient and caregiver populations.

Primary outcome: Recruitment Rate

Time frame: 12 Weeks. Count of participants. Unit: Participants

Measure	Patient n = 29	Caregiver n = 7	Clinician n = 10
Value	21	6	10

Population analysed: 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.

Primary outcome: Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Patient n = 17	Caregiver n = 6	Clinician n = 0
Value	5.9 (0.9)	5.9 (1.1)	–

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients	0 of 20 (0%)	0 of 20 (0%)	1 of 20
Caregivers	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Clinicians	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38935428LoCastro M, Wang Y, Yu T, Mortaz-Hedjri S, Mendler J, Norton S, Bernacki R, Carroll T, Klepin H, Wedow L, Goonan S, Erdos H, Bagnato B, Liesveld J, Huselton E, Kluger B, Loh KP. Clinicians' Perspectives on the Telehealth Serious Illness Care Program for Older Adults With Myeloid Malignancies: Single-Arm Pilot Study. JMIR Form Res. 2024 Jun 27;8:e58503. doi: 10.2196/58503.
Derived from this study: PubMed 38088668LoCastro M, Mortaz-Hedjri S, Wang Y, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Liesveld J, Huselton E, Kluger B, Loh KP. Telehealth serious illness care program for older adults with hematologic malignancies: a single-arm pilot study. Blood Adv. 2023 Dec 26;7(24):7597-7607. doi: 10.1182/bloodadvances.2023011046.
Derived from this study: PubMed 36521100LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin HD, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger B, Loh KP. Adaptation of Serious Illness Care Program to be delivered via telehealth for older patients with hematologic malignancy. Blood Adv. 2023 May 9;7(9):1871-1884. doi: 10.1182/bloodadvances.2022008996.
Individual participant dataSharing planned: Yes. A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.

Related trials for Acute Myeloid Leukemia

RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kah Poh Loh principal investigator

Univ. of Rochester Wilmot Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - Retention Rate (time frame: 12 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745676, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.