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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Field Test of the Partners in Care Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03806192
• Other study ID #: RG1003619
• Secondary ID: NCI-2018-0362910
• Status: Terminated
• Phase: N/A
• Start date: March 16, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• Telephone-Based Intervention
Attend psychoeducational counseling sessions via telephone

Other:
• Behavioral, Psychological or Informational Intervention
Attend psychoeducational counseling sessions via video teleconference
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recruitment		Up to 1 year
Primary	Rate of enrollment		Up to 1 year
Primary	Rate of completion of 5-session intervention		Up to 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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