A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT04745676|
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : January 18, 2022
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia Myelodysplastic Syndromes||Behavioral: Telehealth|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome|
|Actual Study Start Date :||March 25, 2021|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Telehealth ACP intervention advance care planning intervention
- Feasibility - Retention rate [ Time Frame: 12 Weeks ]Percentage of patients consented to the study ultimately completing all study components
- Recruitment rate [ Time Frame: 12 Weeks ]Percentage of patients who are approached and agree to enroll
- Usability [ Time Frame: 12 Weeks ]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.
- Pre-post changes [ Time Frame: 12 Weeks ]Disease Understanding - A questionnaire assessing patient and caregiver's prognostic understanding of illness.
- Pre-post changes [ Time Frame: 12 Weeks ]General Anxiety Disorder-7 (GAD-7): A 7-item screening tool for anxiety (range 0-21, higher score indicates greater anxiety symptoms)
- Pre-post changes [ Time Frame: 12 Weeks ]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
- Pre-post changes [ Time Frame: 12 Weeks ]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
- Pre-post changes [ Time Frame: 12 Weeks ]
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.
- Post-intervention only [ Time Frame: 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745676
|Contact: Kah Poh Loh||585-275-4401||Kahpoh_Loh@URMC.Rochester.edu|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Kah Poh Loh 585-275-4401 Kahpoh_Loh@URMC.Rochester.edu|
|Principal Investigator: Kah Poh Loh|
|Principal Investigator:||Kah Poh Loh||Univ. of Rochester Wilmot Cancer Center|