N/A
N=36
A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Acute Myeloid Leukemia · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT04745676 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Feasibility - Retention Rate — 19; 6; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telehealth (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Retention Rate |
19; 6; 10 | — |
| PRIMARY Recruitment Rate |
21; 6; 10 | — |
| PRIMARY Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ) |
5.9; 5.9 | — |
| SECONDARY Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7) |
0.1; -2.8 | — |
| SECONDARY Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9) |
0.4; -1.0 | — |
| SECONDARY Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer |
0.3; -1.3 | — |
| SECONDARY Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) |
-3.3 | — |
| SECONDARY Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ) |
18.3; 18.2 | — |
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).
Eligibility Criteria
Inclusion Criteria for Patients:
- 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
Exclusion Criteria: N/A
Inclusion Criteria for Caregivers
- Age ≥21 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: N/A
Data sourced from ClinicalTrials.gov (NCT04745676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.