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

Depression Clinical Trial

Official title:

Nursing Intervention for Family Caregivers of HCT Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01341873
• Other study ID #: 10235
• Secondary ID: NCI-2011-00574
• Status: Withdrawn
• Phase: N/A
• First received: April 21, 2011
• Last updated: April 20, 2012
• Start date: May 2012

Study information

• Verified date: April 2012
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Fatigue

Intervention

Other:
• educational intervention
Undergo APN FCI
• psychosocial support for caregiver
Undergo APN FCI

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Through the use of questionnaires, comparison of resource use between the experimental and control groups		12 months after discharge	No
Primary	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	No
Secondary	Through the use of questionnaires, measure FCs satisfaction with the FCI		12 months after discharge	No