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Clinical Trials/NCT01341873
NCT01341873
Withdrawn
N/A

Nursing Intervention for Family Caregivers of HCT Patients

City of Hope Medical Center0 sitesMay 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorder
Sponsor
City of Hope Medical Center
Primary Endpoint
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.
Status
Withdrawn
Last Updated
14 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
October 2016
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 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

Time Frame: 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.

Time Frame: 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

Time Frame: 12 months after discharge

Through the use of questionnaires, comparison of resource use between the experimental and control groups

Time Frame: 12 months after discharge

Secondary Outcomes

  • Through the use of questionnaires, measure FCs satisfaction with the FCI(12 months after discharge)

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