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Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia

Primary Purpose

Acute Myeloid Leukemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-Based Intervention
Behavioral, Psychological or Informational Intervention
Questionnaire Administration
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Myeloid Leukemia focused on measuring Caregiver

Eligibility Criteria

18 Years - 82 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of AML within the recent 2 months
  • Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together
  • Patient must have no other concurrent cancer diagnosis except for basal or squamous cell
  • Caregiver must be able to sustain up to 60 minutes of interaction with patient educator
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together
  • The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell
  • Caregiver cannot sustain up to 60 minutes of interaction with the patient educator
  • Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (psychoeducational counseling sessions via telephone)

Group B (psychoeducational counseling sessions in person)

Arm Description

Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.

Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.

Outcomes

Primary Outcome Measures

Rate of recruitment
Rate of enrollment
Rate of completion of 5-session intervention

Secondary Outcome Measures

Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.

Full Information

First Posted
January 14, 2019
Last Updated
June 18, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03806192
Brief Title
Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia
Official Title
A Field Test of the Partners in Care Program
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to insufficient funding
Study Start Date
March 16, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.
Detailed Description
OUTLINE: Participants are randomized to 1 of 2 groups. GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone. GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference. After completion of study, participants are followed up at 4 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Site intermediary and referring MD
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (psychoeducational counseling sessions via telephone)
Arm Type
Experimental
Arm Description
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
Arm Title
Group B (psychoeducational counseling sessions in person)
Arm Type
Experimental
Arm Description
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Attend psychoeducational counseling sessions via telephone
Intervention Type
Other
Intervention Name(s)
Behavioral, Psychological or Informational Intervention
Intervention Description
Attend psychoeducational counseling sessions via video teleconference
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Rate of recruitment
Time Frame
Up to 1 year
Title
Rate of enrollment
Time Frame
Up to 1 year
Title
Rate of completion of 5-session intervention
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
Description
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Time Frame
Baseline up to 4 months
Title
Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
Description
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Time Frame
Baseline up to 4 months
Title
Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
Description
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Time Frame
Baseline up to 4 months
Title
Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
Description
Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.
Time Frame
Baseline up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of AML within the recent 2 months Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together Patient must have no other concurrent cancer diagnosis except for basal or squamous cell Caregiver must be able to sustain up to 60 minutes of interaction with patient educator Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell Caregiver cannot sustain up to 60 minutes of interaction with the patient educator Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Lewis
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Partners in Care Program for Caregivers of Patients With Acute Myeloid Leukemia

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