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

NCT ID: NCT03806192

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-16

Study Completion Date

2020-11-30

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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
Site intermediary and referring MD

Study Groups

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Group A (psychoeducational counseling sessions via telephone)

Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.

Group Type EXPERIMENTAL

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Attend psychoeducational counseling sessions via telephone

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group B (psychoeducational counseling sessions in person)

Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.

Group Type EXPERIMENTAL

Behavioral, Psychological or Informational Intervention

Intervention Type OTHER

Attend psychoeducational counseling sessions via video teleconference

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Telephone-Based Intervention

Attend psychoeducational counseling sessions via telephone

Intervention Type BEHAVIORAL

Behavioral, Psychological or Informational Intervention

Attend psychoeducational counseling sessions via video teleconference

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frances Lewis

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-03629

Identifier Type: REGISTRY

Identifier Source: secondary_id

10048

Identifier Type: OTHER

Identifier Source: secondary_id

RG1003619

Identifier Type: -

Identifier Source: org_study_id

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