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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: UR-GOAL communication tool
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Experimental Arm: single

Arm Description

The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.

Outcomes

Primary Outcome Measures

Feasibility
Recruitment rates (percentage of patients who are approached and agree to enroll)
System Usability Scale
Score on 10-item scale, ranging 0-100; higher score corresponds to greater usability

Secondary Outcome Measures

Pre-post changes in the following outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)
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
Pre-post changes in the following outcomes: Disease Knowledge
A 14-item questionnaire assessing patients and caregivers' understanding of AML; ranging 0-14; higher score corresponds to greater understanding
Pre-post changes in the following outcomes: Disease Understanding
A questionnaire assessing patient and caregiver's prognostic understanding of illness and preferences regarding life expectancy discussions.
Pre-post changes in the following outcomes: General Anxiety Disorder-7
A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms
Pre-post changes in the following outcomes: Geriatric Depression Scale-15
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
Pre-post changes in the following outcomes: Patient Health Questionnaire-2 (PHQ-2
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
Pre-post changes in the following outcomes: Caregiver Ryff's Environmental Mastery
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
Post-intervention only: Health Care Communication Questionnaire
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.
Post-intervention only: Shared Decision-Making Questionnaire (SDM-Q-9)
A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process. Ranging 6-54, greater score corresponds to greater satisfaction
Preparation for Decision Making Scale
A 10-item questionnaire assessing effect of the educational material on decision making. Ranging 10-100, greater score corresponds to greater preparation.

Full Information

First Posted
November 5, 2020
Last Updated
October 11, 2022
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04625413
Brief Title
A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Official Title
A Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 11, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Evaluate the usability and feasibility of a patient-centered communication tool (UR-GOAL)
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Experimental Arm: single
Arm Type
Experimental
Arm Description
The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awareness.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: UR-GOAL communication tool
Intervention Description
The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene
Primary Outcome Measure Information:
Title
Feasibility
Description
Recruitment rates (percentage of patients who are approached and agree to enroll)
Time Frame
One week
Title
System Usability Scale
Description
Score on 10-item scale, ranging 0-100; higher score corresponds to greater usability
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Pre-post changes in the following outcomes:Perceived Efficacy in Patient-Physician Interactions (PEPPI)
Description
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
Time Frame
Two weeks
Title
Pre-post changes in the following outcomes: Disease Knowledge
Description
A 14-item questionnaire assessing patients and caregivers' understanding of AML; ranging 0-14; higher score corresponds to greater understanding
Time Frame
Two weeks
Title
Pre-post changes in the following outcomes: Disease Understanding
Description
A questionnaire assessing patient and caregiver's prognostic understanding of illness and preferences regarding life expectancy discussions.
Time Frame
Two weeks
Title
Pre-post changes in the following outcomes: General Anxiety Disorder-7
Description
A 7-item screening tool for anxiety; ranging 7-21; higher score corresponds to greater anxiety symptoms
Time Frame
Two weeks
Title
Pre-post changes in the following outcomes: Geriatric Depression Scale-15
Description
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
Time Frame
Two Weeks
Title
Pre-post changes in the following outcomes: Patient Health Questionnaire-2 (PHQ-2
Description
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
Time Frame
Two weeks
Title
Pre-post changes in the following outcomes: Caregiver Ryff's Environmental Mastery
Description
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
Time Frame
Two weeks
Title
Post-intervention only: Health Care Communication Questionnaire
Description
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.
Time Frame
Two weeks
Title
Post-intervention only: Shared Decision-Making Questionnaire (SDM-Q-9)
Description
A 9-item reliable questionnaire assessing patient satisfaction with the medical decision-making process. Ranging 6-54, greater score corresponds to greater satisfaction
Time Frame
Two weeks
Title
Preparation for Decision Making Scale
Description
A 10-item questionnaire assessing effect of the educational material on decision making. Ranging 10-100, greater score corresponds to greater preparation.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
The data will be available for 7 years from accrual of the first subject.

Learn more about this trial

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

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