Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant
NCT ID: NCT01341873
Last Updated: 2012-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
educational intervention
Undergo APN FCI
psychosocial support for caregiver
Undergo APN FCI
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Group II (control)
FCs receive standard supportive care.
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Interventions
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educational intervention
Undergo APN FCI
psychosocial support for caregiver
Undergo APN FCI
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Living within a 50 mile radius of City of Hope
Exclusion Criteria
* Caregivers who live more than 50 miles from City of Hope
21 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marcia Grant, RN, DNSC
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Other Identifiers
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NCI-2011-00574
Identifier Type: REGISTRY
Identifier Source: secondary_id
10235
Identifier Type: -
Identifier Source: org_study_id
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