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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Field Test of the Partners in Care Program

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Behavioral: Telephone-Based Intervention
* Other: Behavioral, Psychological or Informational Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver