Nursing Intervention for Family Caregivers of HCT Patients
21 Years
N/A
Both
Anxiety Disorder, Depression, Fatigue
Trial Information
Nursing Intervention for Family Caregivers of HCT Patients
PRIMARY OBJECTIVES:
I. Test the effects of an advanced practice nursing (APN) intervention for family caregivers
(FCs) of hematopoietic cell transplant (HCT) patients in the experimental group on FC
quality of life, psychological distress, caregiver burden, caregiver skills preparedness as
compared to FCs in the control group.
II. Describe self-care behaviors for FCs of HCT patients and compare them between the
experimental and control groups.
III. Describe resource use by FCs comparing the experimental and control groups.
IV. Identify subgroups of FCs who benefit most from the family caregiver intervention (FCI)
in relation to sociodemographic characteristics, caregiver health status, and patient
characteristics.
SECONDARY OBJECTIVES:
I. Describe family caregivers' satisfaction with the FCI.
OUTLINE: FCs are randomized to 1 of 2 groups.
GROUP I: FCs receive 4 sessions of an APN FCI beginning during the admission for transplant
and continuing for up to 100 days after transplant.
GROUP II: FCs receive standard supportive care.
After completion of study, FCs are followed up at 3, 6, and 12 months.
Inclusion Criteria:
- The primary family caregiver as identified by a hematologic cancer patient who is
scheduled for a single allogeneic bone marrow or stem cell transplant; the definition
of a family caregiver for the purposes of this proposal refers to either a family
member or friend that is identified by the patient as being the primary caregiver
- Living within a 50 mile radius of City of Hope
Exclusion Criteria:
- Caregivers who are unable to read English or Spanish consent forms
- Caregivers who live more than 50 miles from City of Hope
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care
Outcome Measure:
Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring quality of life and psychological distress as compared to the FCs in the control group.
Outcome Time Frame:
12 months after discharge
Safety Issue:
No
Principal Investigator
Marcia Grant, RN, DNSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
10235
NCT ID:
NCT01341873
Start Date:
May 2012
Completion Date:
Related Keywords:
- Anxiety Disorder
- Depression
- Fatigue
- Anxiety Disorders
- Depression
- Depressive Disorder
- Fatigue
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