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

University of Washington12 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

Telephone-Based InterventionBEHAVIORAL

Attend psychoeducational counseling sessions via telephone

Behavioral, Psychological or Informational InterventionOTHER

Attend psychoeducational counseling sessions via video teleconference

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 YearsMax age: 82 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Rate of recruitment

Time frame: Up to 1 year

Rate of enrollment

Time frame: Up to 1 year

Rate of completion of 5-session intervention

Time frame: Up to 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline up to 4 months

Data from ClinicalTrials.gov

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