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

Not Applicable

Withdrawn

• Conditions: Depression; Anxiety Disorder; Fatigue
• Interventions: Other: educational intervention; Other: psychosocial support for caregiver; Procedure: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT01341873
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-20
• Last Update Posted: 2012-04-23
• Study Start: 2012-05
• Primary Completion: 2016-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (FCI)	questionnaire administration	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 (control)	questionnaire administration	FCs receive standard supportive care.
Group I (FCI)	educational intervention	FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.
Group I (FCI)	psychosocial support for caregiver	FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.
Group I (FCI)	quality-of-life assessment	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 (control)	quality-of-life assessment	FCs receive standard supportive care.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
Through the use of questionnaires, measure FCs satisfaction with the FCI	12 months after discharge