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

April 20, 2012 updated by: City of Hope Medical Center

Nursing Intervention for Family Caregivers of HCT Patients

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Other: educational intervention
Undergo APN FCI
Other Names:
  • intervention, educational
Other: psychosocial support for caregiver
Undergo APN FCI
Other: Group II (control)
FCs receive standard supportive care.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
12 months after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Through the use of questionnaires, measure FCs satisfaction with the FCI
Time Frame: 12 months after discharge
12 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marcia Grant, RN, DNSC, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 25, 2011

First Posted (Estimate)

April 26, 2011

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10235
  • NCI-2011-00574 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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