Myeloid MalignancySICP RCTNCT05875805
A Telehealth Advance Care Planning Intervention
A study testing Telehealth Serious Illness Care Program in people with Myeloid Malignancy and Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
Trial summary
The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Telehealth Serious Illness Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
- Being managed in the outpatient settings
- Able to provide informed consent
- English-speaking
- Age ≥18 years
Show all 10Show 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
- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit
Who cannot join
- None
- None
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Kah Poh Loh, MD, 585-276-4353, kahpoh_loh@urmc.rochester.edu
About this study
Official title: A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.
Read the detailed description
The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.
- Conditions
- Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis
- Being tested
- Telehealth Serious Illness Care Program, Education Control
- Keywords
- Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Serious Illness Care ProgramBehavioural
The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Education ControlOther
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Serious Illness Care Program | Experimental | The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide). Receives: Behavioral: Telehealth Serious Illness Care Program |
| Control | Other | Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version" Receives: Other: Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Communication: Health Care Climate Questionnaire
5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better
Measured: Month 2
Secondary outcomes (3)
Distress: Distress Thermometer
1-item question for distress, range 0-10; higher scores indicate greater distress
Measured: Month 2
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
7-item screening tool for anxiety symptoms, total range 0-21); higher scores indicate greater anxiety symptoms
Measured: Month 2
Completion of advance directives
Percentage of patients who complete advance directives which include the Medical or Physician Orders for Life-Sustaining Treatment (MOST/POLST) forms, living will, durable power of attorney for healthcare, and healthcare proxy forms, as well as date of completion
Measured: Throughout the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 May 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myeloid MalignancyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
- Investigators
- Kah Poh Loh, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875805
- Sponsor's protocol ID
- UOCPC23038
- Acronym
- SICP RCT
- Status last verified
- Jul 2026
- First submitted
- 16 May 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
Publications
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 36521100LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10.
PubMed 36100548
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 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 Myeloid Malignancies: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05875805
- Acronym / sponsor ID
- SICP RCT / UOCPC23038
- Conditions
- Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis
- Keywords
- Older adults, Myeloid malignancies, Geriatric hematology, Serious illness conversations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.
Detailed description
The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Serious Illness Care Program | Experimental | Behavioral: Telehealth Serious Illness Care ProgramThe adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide). |
| Control | Other | Other: Education ControlEducation materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version" |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥60 years
- A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
- Being managed in the outpatient settings
- Able to provide informed consent
- English-speaking
Key exclusion criteria (3 listed)
- None
- None
- None
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 |
|---|---|---|
| Telehealth Serious Illness Care ProgramThe adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide). | Behavioural | Telehealth Serious Illness Care Program |
| Education ControlEducation materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version" | Other | Control |
Primary outcome
Healthcare Communication: Health Care Climate Questionnaire
Time frame: Month 2
5-item questionnaire assessing patients' and caregivers' satisfaction with patient-clinician communication, range 0-20; higher score is better
3 secondary outcomes
Distress: Distress Thermometer
Time frame: Month 2
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Month 2
Completion of advance directives
Time frame: Throughout the study, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: 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.
- Background: PubMed 36100548LoCastro M, Sanapala C, Mendler JH, Norton S, Bernacki R, Carroll T, Klepin H, Watson E, Liesveld J, Huselton E, O'Dwyer K, Baran A, Flannery M, Kluger BM, Loh KP. Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes. J Geriatr Oncol. 2023 Jan;14(1):101374. doi: 10.1016/j.jgo.2022.09.003. Epub 2022 Sep 10.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators if requested. Published papers will be made available in portable document format.
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RecruitingPhase 2
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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
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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.
Kah Poh Loh principal investigator
University of Rochester
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 Serious Illness Care Program in people with Myeloid Malignancy and Acute Myeloid Leukemia, 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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kah Poh Loh, MD (585-276-4353, Kahpoh_Loh@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Communication: Health Care Climate Questionnaire (time frame: Month 2). 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 NCT05875805, which also lists 2 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 11 Sep 2026.