Acute Myeloid Leukemia
Conditions
Keywords
Caregiver
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.
Interventions
BEHAVIORALTelephone-Based Intervention
Attend psychoeducational counseling sessions via telephone
Attend psychoeducational counseling sessions via video teleconference
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
Site intermediary and referring MD
Eligibility
Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed