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Clinical Trials/NCT03806192
NCT03806192
Terminated
Not Applicable

A Field Test of the Partners in Care Program

University of Washington1 site in 1 country12 target enrollmentStarted: March 16, 2019Last updated:

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
12
Locations
1
Primary Endpoint
Rate of recruitment

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Masking Description

Site intermediary and referring MD

Eligibility Criteria

Ages
18 Years to 82 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Rate of recruitment

Time Frame: Up to 1 year

Rate of enrollment

Time Frame: Up to 1 year

Rate of completion of 5-session intervention

Time Frame: Up to 1 year

Secondary Outcomes

  • Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])(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])(Baseline up to 4 months)
  • Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist(Baseline up to 4 months)
  • Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)(Baseline up to 4 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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