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A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists

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ClinicalTrials.gov Identifier: NCT04625413
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : October 12, 2021
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 patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Behavioral: Behavioral: UR-GOAL communication tool Not Applicable

Detailed Description:
Older adults with AML and their caregivers may benefit from help and support in understanding their treatment options. This pilot study seeks to evaluate the usability and feasibility of the UR-GOAL communication tool. The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022


Arm Intervention/treatment
Experimental: Experimental: Experimental Arm: single
The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.
Behavioral: Behavioral: UR-GOAL communication tool
The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene




Primary Outcome Measures :
  1. Feasibility [ Time Frame: One week ]
    Recruitment rates (percentage of patients who are approached and agree to enroll)

  2. System Usability Scale [ Time Frame: Two weeks ]
    Score on 10-item scale, ranging 0-100; higher score corresponds to greater usability


Secondary Outcome Measures :
  1. Pre-post changes in the following outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI) [ Time Frame: Two weeks ]
    A valid and reliable assessment of perceived self-efficacy of older patients interacting with physicians; score on 5-item scale, ranging 5-25; higher score corresponds to greater perceived efficacy

  2. Pre-post changes in the following outcomes: Disease Knowledge [ Time Frame: Two weeks ]
    A 14-item questionnaire assessing patients and caregivers' understanding of AML; ranging 0-14; higher score corresponds to greater understanding

  3. Pre-post changes in the following outcomes: Disease Understanding [ Time Frame: Two weeks ]
    A questionnaire assessing patient and caregiver's prognostic understanding of illness and preferences regarding life expectancy discussions.

  4. Pre-post changes in the following outcomes: General Anxiety Disorder-7 [ Time Frame: Two weeks ]
    A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms

  5. Pre-post changes in the following outcomes: Geriatric Depression Scale-15 [ Time Frame: Two Weeks ]
    A 15-item valid and reliable screening tool for depression in older adults. This will be used for patients; ranging 0-15; higher score corresponds to greater depressive symptoms

  6. Pre-post changes in the following outcomes: Patient Health Questionnaire-2 (PHQ-2 [ Time Frame: Two weeks ]
    A 2-item valid and reliable screening tool depression in the general population. This will be used for caregivers. Ranging 0-6; higher score corresponds to greater depressive symptoms

  7. Pre-post changes in the following outcomes: Caregiver Ryff's Environmental Mastery [ Time Frame: Two weeks ]
    A 7-item questionnaire measuring whether the respondent makes effective use of opportunities and has a sense of mastery in managing environmental factors and activities, including managing everyday affairs and creating situations to benefit personal needs. Ranging 7-35; higher score corresponds to greater depressive

  8. Post-intervention only: Health Care Communication Questionnaire [ Time Frame: Two weeks ]
    A questionnaire assessing patients' and caregivers' satisfaction with patient-oncologist communication. 1) Satisfaction with communication about overall health, 6-items, ranging from 6-30, greater score corresponds to greater satisfaction; 2) Satisfaction with communication about aging-related concerns, ranging from 7-35, greater score corresponds to greater satisfaction.

  9. Post-intervention only: Shared Decision-Making Questionnaire (SDM-Q-9) [ Time Frame: Two weeks ]
    A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process. Ranging 6-54, greater score corresponds to greater satisfaction

  10. Preparation for Decision Making Scale [ Time Frame: Two weeks ]
    A 10-item questionnaire assessing effect of the educational material on decision making. Ranging 10-100, greater score corresponds to greater preparation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Patients:

  • Age ≥60 years (conventional definition of older age in AML)
  • Newly diagnosed AML
  • Considering treatment
  • Able to provide informed consent
  • English-speaking

Inclusion Criteria for Caregivers:

  • Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient.
  • Able to provide informed consent
  • English-speaking

Inclusion Criteria for Oncologists:

  • A practicing oncologist
  • At least one of their patients are recruited to the study
  • English-speaking

Exclusion Criteria: None


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): NCT04625413


Contacts
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Contact: Terri Lloyd 5852765652 Terri1_Lloyd@urmc.rochester.edu
Contact: Kah Poh Loh 585275863 Kahpoh_Loh@URMC.Rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14623
Contact: Kah Poh Loh         
Sponsors and Collaborators
University of Rochester
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Responsible Party: Kah Poh Loh, Senior Instructor, Department of Medicine-Hematology/Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT04625413    
Other Study ID Numbers: UCCS20090
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
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
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms