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

A Field Test of the Partners in Care Program

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.

Study Overview

• Status: Terminated
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention; Other: Behavioral, Psychological or Informational Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (psychoeducational counseling sessions via telephone); Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Telephone-Based Intervention; Attend psychoeducational counseling sessions via telephone
Experimental: Group B (psychoeducational counseling sessions in person); Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.	Other: Questionnaire Administration; Ancillary studies; Other: Behavioral, Psychological or Informational Intervention; Attend psychoeducational counseling sessions via video teleconference

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of recruitment	Up to 1 year
Rate of enrollment	Up to 1 year
Rate of completion of 5-session intervention	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 4 months
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.	Baseline up to 4 months
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.	Baseline up to 4 months
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.	Baseline up to 4 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Frances Lewis, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Caregiver
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: RG1003619; NCI-2018-03629 (Registry Identifier: NCI / CTRP); 10048 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No