Clinical trial · Interventional
A Telehealth Advance Care Planning Intervention
A Telehealth Advance Care Planning Intervention for Older Patients With Myeloid Malignancies: A Pilot Randomized Controlled Trial
NCT05875805CI-TRIAL-00107281SICP RCTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic/Myeloproliferative Neoplasm | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Myeloid Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education Control | Other | — | UNRESOLVED |
| Telehealth Serious Illness Care Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Telehealth Serious Illness Care Program
- description
- 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).
- interventionNames
- Behavioral: Telehealth Serious Illness Care Program
- type
- OTHER
- label
- Control
- description
- Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
- interventionNames
- Other: Education Control
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion and Exclusion Criteria for Patients Inclusion criteria: * 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 Exclusion criteria: \- None Inclusion and Exclusion Criteria for Caregivers Inclusion criteria: * Age ≥18 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 Exclusion criteria: \- None Inclusion and Exclusion Criteria for Oncology Providers Inclusion criteria: \- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit Exclusion criteria: \- None
References
Publications (2)
- BACKGROUNDLoCastro 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. PMID 36521100
- BACKGROUNDLoCastro 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. PMID 36100548