A Telehealth Advance Care Planning Intervention

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	60 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion and Exclusion Criteria for Patients.

Inclusion Criteria:

- Age ≥60 years.

- A diagnosis of acute myeloid leukemia, myelodysplastic syndrome (MDS), or similar myeloid malignancies (including but not limited to MDS/myeloproliferative neoplasms 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05875805
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Rochester
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis

Additional Details

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.

Arms & Interventions

Arms

Experimental: Telehealth Serious Illness Care Program

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).

Other: Control

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Interventions

Behavioral: - Telehealth Serious Illness Care Program

Other: - Education Control

Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester, Rochester, New York

Status

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Kah Poh Loh, MD

[email protected]

585-276-4353

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