Clinical trial NCT03806192: 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
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Caregiver
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of recruitment
timeFrame: Up to 1 year
measure: Rate of enrollment
timeFrame: Up to 1 year
measure: Rate of completion of 5-session intervention
timeFrame: Up to 1 year
Secondary outcomes:
measure: Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])
timeFrame: Baseline up to 4 months
measure: Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])
timeFrame: Baseline up to 4 months
measure: Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist
timeFrame: Baseline up to 4 months
measure: Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)
timeFrame: Baseline up to 4 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Frances Lewis
role: PRINCIPAL_INVESTIGATOR
References: