Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant

Study Overview
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Brief Summary
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This randomized clinical trial studies nursing intervention in supporting family caregivers (FCs) of patients undergoing stem cell transplant. A nursing intervention may help prepare FCs support the recovery of the patients

Detailed Description
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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.

Official Title
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Nursing Intervention for Family Caregivers of HCT Patients

Conditions
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Anxiety Disorder, Depression, Fatigue

Intervention / Treatment
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* Other: educational intervention
* Other: psychosocial support for caregiver
* Procedure: quality-of-life assessment
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (FCI)<br>FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant. | Other: educational intervention<br>* Undergo APN FCI<br>* Other names: intervention, educational;Other: psychosocial support for caregiver<br>* Undergo APN FCI<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|
| Other: Group II (control)<br>FCs receive standard supportive care. | Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 months after discharge | 
| Test the effects of an advanced practice nursing (APN) intervention for family caregivers (FCs) in the experimental group using questionnaires measuring caregiver burden and skills preparedness as compared to the FCs in the control group. |  | 12 months after discharge | 
| Through the use of questionnaires, comparison of self-care behaviors for FCs of Hematopoietic Cell Transplant (HCT) patients between the experimental and control groups |  | 12 months after discharge | 
| Through the use of questionnaires, comparison of resource use between the experimental and control groups |  | 12 months after discharge | 
| Through the use of questionnaires, identification of subgroups of FCs who benefit most from the Family Care Intervention (FCI) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics |  | 12 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Through the use of questionnaires, measure FCs satisfaction with the FCI |  | 12 months after discharge |