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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00574 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The protocol was not funded by the NCI
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (FCI) | Experimental | FCs receive 4 sessions of an APN FCI beginning during the admission for transplant and continuing for up to 100 days after transplant. |
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| Group II (control) | Other | FCs receive standard supportive care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Undergo APN FCI |
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| Measure | Description | 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. | 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. | 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 | 12 months after discharge | |
| Through the use of questionnaires, comparison of resource use between the experimental and control groups | 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 | 12 months after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Through the use of questionnaires, measure FCs satisfaction with the FCI | 12 months after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia Grant, RN, DNSC | City of Hope Medical Center | Principal Investigator |
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| psychosocial support for caregiver | Other | Undergo APN FCI |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D000067250 | Psychiatric Rehabilitation |
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006282 | Health Personnel |
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