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

This study has been withdrawn prior to enrollment.
(The protocol was not funded by the NCI)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01341873
First received: April 21, 2011
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Anxiety Disorder
Depression
Fatigue
Other: educational intervention
Other: psychosocial support for caregiver
Procedure: quality-of-life assessment
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Nursing Intervention for Family Caregivers of HCT Patients

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Through the use of questionnaires, comparison of resource use between the experimental and control groups [ Time Frame: 12 months after discharge ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Through the use of questionnaires, measure FCs satisfaction with the FCI [ Time Frame: 12 months after discharge ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2012
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (FCI)
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
Undergo APN FCI
Other Name: intervention, educational
Other: psychosocial support for caregiver
Undergo APN FCI
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Group II (control)
FCs receive standard supportive care.
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341873

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Marcia Grant, RN, DNSC City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01341873     History of Changes
Other Study ID Numbers: 10235, NCI-2011-00574
Study First Received: April 21, 2011
Last Updated: April 20, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Behavioral Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on October 22, 2014