Advance care planning in older patients with acute myeloid leukemia and myelodysplastic syndromes.
Marissa LoCastro, Chandrika Sanapala, Jason H Mendler...
https://pubmed.ncbi.nlm.nih.gov/36100548/Actively Recruiting
Led by University of Rochester · Updated on 2026-04-03
207
Participants Needed
1
Research Sites
13 weeks
Total Duration
This research aims to evaluate the preliminary effects of a telehealth-delivered Serious Illness Care Program SICP on communication about healthcare, patient anxiety, distress, and completion of advance directives for older adults with acute myeloid leukemia, myelodysplastic syndrome, and related myeloid cancers. The trial is a pilot randomized study comparing this telehealth program to an education control. The SICP is designed to improve serious illness conversations between patients and their doctors through structured guidance and support. The study involves two groups one receives the telehealth Serious Illness Care Program, which includes clinician tools like the Serious Illness Conversation Guide, patient education pamphlets on serious illness conversations, and guides for caregiver involvement. The other group receives educational materials about communication in cancer care provided by the National Cancer Institute. The intervention engages patients, caregivers, clinicians, and the healthcare system to promote better communication and planning. Participants will be assessed primarily on healthcare communication two months after starting the study. Secondary measures include distress levels, anxiety symptoms, and the completion of advance directives tracked throughout the study for up to two years. The study involves ongoing evaluations through questionnaires and monitoring to understand how the telehealth program impacts communication and patient well-being. The entire study participation timeline extends up to two years for some outcomes.
CONDITIONS
A Telehealth Advance Care Planning Intervention
K
Kah Poh Loh, MD
B
Becky Gravenstede
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University of Rochester
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Telehealth Serious Illness Care Program | Education Control (Communication in Cancer Care Materials) |
|---|---|---|
| What it is | A multilevel telehealth intervention delivering advance care planning (ACP) support to patients, their caregivers, and clinicians. Includes structured conversation guides, educational pamphlets for patients, and tools for caregiver involvement, all delivered via telehealth. | A control intervention providing educational materials developed by the National Cancer Institute that focus on communication in cancer care, delivered to patients. |
| Role in the trial | Serves as the experimental communication and ACP support intervention, designed to improve patient-clinician and patient-caregiver discussions about prognosis and care wishes. | Acts as the control, intended to provide standard educational baseline for comparison of communication and ACP outcomes. |
| Primary use or goal | To enhance serious illness conversations and advance care planning, promote patient and caregiver engagement, and foster shared decision-making among older adults with myeloid malignancies. | To provide standard information on communication in cancer care to patients for the purpose of supporting better healthcare communication. |
| How it is given or performed | Delivered via telehealth sessions. Clinicians use structured conversation guides and give patients and their caregivers educational and family communication materials. | Educational booklets provided to patients, focused on established resources from the NCI. |
| Evidence status | Ongoing trial; results for this specific telehealth ACP program are not yet established. Prior research supports feasibility of similar interventions delivered via telehealth for patients with hematologic malignancies. | Educational booklets from the NCI are routinely used for communication improvement in cancer care, but are not themselves designed as intensive behavioral interventions and may have limited impact on completion of advance care planning. |
| Important limitations | Results are not yet available; generalizability outside a telehealth outpatient oncology setting and for non-English speakers is unproven. Previous feasibility adaptation did not establish long-term clinical outcomes. | Educational materials alone may not fully support complex advance care planning needs. Standard written resources do not substitute for structured, guided conversations about serious illness between clinicians, patients, and caregivers. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 2 years
Participants engage in a telehealth intervention or receive education materials to support serious illness conversations and advance care planning.
Visits as scheduled via telehealth throughout the study period
Duration - Up to 2 years
Participants are monitored for healthcare communication, distress, anxiety, and completion of advance directives.
Assessments at Month 2 and ongoing monitoring up to 2 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Marissa LoCastro, Chandrika Sanapala, Jason H Mendler...
https://pubmed.ncbi.nlm.nih.gov/36100548/Marissa LoCastro, Chandrika Sanapala, Jason H Mendler...
https://pubmed.ncbi.nlm.nih.gov/36521100/University of Rochester
Lead Sponsor