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

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ClinicalTrials.gov Identifier: NCT03806192
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Caregiver Behavioral: Telephone-Based Intervention Other: Behavioral, Psychological or Informational Intervention Other: Questionnaire Administration Not Applicable

Detailed Description:

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 in person.

After completion of study, participants are followed up at 4 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Site intermediary and referring MD
Primary Purpose: Supportive Care
Official Title: Field Test of the Partners in Care Program
Actual Study Start Date : March 16, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020


Arm Intervention/treatment
Experimental: Group A (psychoeducational counseling sessions via telephone)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
Behavioral: Telephone-Based Intervention
Attend psychoeducational counseling sessions via telephone

Other: Questionnaire Administration
Ancillary studies

Experimental: Group B (psychoeducational counseling sessions in person)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes in person.
Other: Behavioral, Psychological or Informational Intervention
Attend psychoeducational counseling sessions in person

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Rate of recruitment [ Time Frame: Up to 1 year ]
  2. Rate of enrollment [ Time Frame: Up to 1 year ]
  3. Rate of completion of 5-session intervention [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Change in standardized measures of spouse caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI]) [ Time Frame: Baseline up to 4 months ]
    Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.

  2. Change in standardized measures of spouse caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D]) [ Time Frame: Baseline up to 4 months ]
    Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.

  3. Change in standardized measures of spouse caregiver and patients' scores in each group on Spouse Skills Checklist [ Time Frame: Baseline up to 4 months ]
    Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.

  4. Change in standardized measures of spouse caregiver and patients' scores in each group on Cancer Self-efficacy (CASE) [ Time Frame: Baseline up to 4 months ]
    Will assess the within-group changes using the one-sample t-test or the signed-rank test, as appropriate.



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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of AML within the recent 2 months
  • Couples need to write, read, and speak English as one of their languages of choice; have been married or co-inhabiting 6 months or longer in an intimate relationship
  • 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
  • Both heterosexual couples and same sex couples will be eligible
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Couples 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 married or have been co-inhabiting 6 months or longer in an intimate relationship
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806192


Contacts
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Contact: Frances Lewis 206-321-4479 fmlewis@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Frances Lewis         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Frances Lewis Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03806192     History of Changes
Other Study ID Numbers: RG1003619
NCI-2018-03629 ( Registry Identifier: NCI / CTRP )
10048 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms