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

NCT03806192 | Terminated

• 3 other identifiers: RG1003619NCI-2018-0362910048
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Caregiver

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

Group A (psychoeducational counseling sessions via telephone)

EXPERIMENTAL

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

Behavioral: Telephone-Based Intervention; Other: Questionnaire Administration

Group B (psychoeducational counseling sessions in person)

EXPERIMENTAL

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

Other: Behavioral, Psychological or Informational Intervention; Other: Questionnaire Administration

Interventions

Telephone-Based Intervention BEHAVIORAL

Attend psychoeducational counseling sessions via telephone

Group A (psychoeducational counseling sessions via telephone)

Behavioral, Psychological or Informational Intervention OTHER

Attend psychoeducational counseling sessions via video teleconference

Group B (psychoeducational counseling sessions in person)

Questionnaire Administration OTHER

Ancillary studies

Group A (psychoeducational counseling sessions via telephone); Group B (psychoeducational counseling sessions in person)

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Frances Lewis

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Site intermediary and referring MD
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: March 16, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 23, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)