Nursing Intervention in Supporting Family Caregivers of Patients Undergoing Stem Cell Transplant
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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 |
- 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 ]
- 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 |
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 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 Depressive Disorder Fatigue |
Mental Disorders Behavioral Symptoms Mood Disorders Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013