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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04745676
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Kah Poh Loh, University of Rochester

Brief 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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Myelodysplastic Syndromes Behavioral: Telehealth

Detailed 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.

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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


Group/Cohort Intervention/treatment
Experimental
The SICG program consists of the Serious Illness Conversation Guide as well as training and system-level support for physicians to conduct ACP conversations.
Behavioral: Telehealth
Telehealth ACP intervention advance care planning intervention




Primary Outcome Measures :
  1. Feasibility - Retention rate [ Time Frame: 12 Weeks ]
    Percentage of patients consented to the study ultimately completing all study components

  2. Recruitment rate [ Time Frame: 12 Weeks ]
    Percentage of patients who are approached and agree to enroll

  3. 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.


Secondary Outcome Measures :
  1. Pre-post changes [ Time Frame: 12 Weeks ]
    Disease Understanding - A questionnaire assessing patient and caregiver's prognostic understanding of illness.

  2. 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)

  3. 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

  4. 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

  5. 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.


  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newly diagnosed AML (in the prior one month)
Criteria

Inclusion Criteria for Patients:

  • Age ≥60 years (conventional definition of older age in AML)
  • Newly diagnosed AML (in the prior one month)
  • 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


Information from the National Library of Medicine

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


Contacts
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Contact: Kah Poh Loh 585-275-4401 Kahpoh_Loh@URMC.Rochester.edu

Locations
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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         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Kah Poh Loh Univ. of Rochester Wilmot Cancer Center
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Responsible Party: Kah Poh Loh, Senior Instructor, University of Rochester
ClinicalTrials.gov Identifier: NCT04745676    
Other Study ID Numbers: UCCO20134
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
Supporting Materials: Study Protocol
Time Frame: The data will be available for 7 years from accrual of the first subject.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kah Poh Loh, University of Rochester:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions