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

Not Applicable

Terminated

• Conditions: Acute Myeloid Leukemia
• Interventions: Behavioral: Telephone-Based Intervention; Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration

• Registration Number: NCT03806192
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-16
• Study Start: 2019-03-16
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (psychoeducational counseling sessions in person)	Questionnaire Administration	Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
Group A (psychoeducational counseling sessions via telephone)	Questionnaire Administration	Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
Group A (psychoeducational counseling sessions via telephone)	Telephone-Based Intervention	Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
Group B (psychoeducational counseling sessions in person)	Behavioral, Psychological or Informational Intervention	Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])	Baseline up to 4 months	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])	Baseline up to 4 months	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	Baseline up to 4 months	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)	Baseline up to 4 months	Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States