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

City of Hope

Status: Withdrawn

Conditions: Anxiety Disorder; Depression; Fatigue

Treatments: Other: psychosocial support for caregiver; Other: questionnaire administration; Other: educational intervention; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01341873

10235

NCI-2011-00574 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Group I (FCI)

Experimental group

Description:

FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant.

Treatment:

Procedure: quality-of-life assessment

Other: educational intervention

Other: questionnaire administration

Other: psychosocial support for caregiver

Group II (control)

Other group

Description:

FCs receive standard supportive care.

Treatment:

Procedure: quality-of-life assessment

Other: questionnaire administration