A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Acute Myeloid Leukemia Clinical Trial

Official title:

A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04745676
• Other study ID #: UCCO20134
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), their caregivers, and oncologists.

Description:

Older adults with AMLamd MDS are more likely to receive aggressive care and less likely to utilize hospice at the end-of-life. Advance care planning (ACP) intervention delivered through telehealth may improve patient-reported outcomes and end-of-life care in this population. This pilot study seeks to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention. We will adapt the Serious Illness Care Program.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Behavioral:
• Telehealth
Telehealth ACP intervention advance care planning intervention

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Retention rate	Percentage of patients consented to the study ultimately completing all study components	12 Weeks
Primary	Recruitment rate	Percentage of patients who are approached and agree to enroll	12 Weeks
Primary	Usability	Telehealth Usability Questionnaire (TUQ) - A questionnaire (22 questions scored from 1 to 7) assessing the usability of telehealth implementation, average of >5 will be considered usable.	12 Weeks
Secondary	Pre-post changes	Disease Understanding - A questionnaire assessing patient and caregiver's prognostic understanding of illness.	12 Weeks
Secondary	Pre-post changes	General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)	12 Weeks
Secondary	Pre-post changes	Patient Health Questionnaire-9 (PHQ-9): A 9-item valid and reliable screening tool depression in the general population (range 0-27, higher score indicates greater depressive symptoms). This will be used for patients and caregivers	12 Weeks
Secondary	Pre-post changes	Distress Thermometer: A self-reported tool to screen for symptoms of distress, using a 0-10 rating scale (higher score indicates greater distress level). This will be used for patients and caregivers	12 Weeks
Secondary	Pre-post changes	Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu): Consists of 17 questions on the general module and 17 leukemia-specific questions, score ranges from 0-176, higher score indicates better quality of life). This will be used for patients.; Caregiver Quality of Life Index-Cancer: Consists of 35 questions, score ranges from 0-140. This will be used for caregivers.	12 Weeks
Secondary	Post-intervention only	Health Care Communication Questionnaire (HCCQ): A questionnaire assessing patients' and caregivers' satisfaction with patient-oncologist communication (12 items for patients and 17 items for caregivers, range from 12-60 and 17-85, respectively), higher score indicates greater satisfaction with communication.	12 weeks