A Standardized Nursing Intervention Protocol for HCT Patients
Study Details
Study Description
Brief Summary
RATIONALE: Visiting patients at home to teach them about self care after a stem cell transplant may be more effective than standard therapy in improving quality of life.
PURPOSE: This clinical trial is studying home visits to see how well they work compared with standard therapy in treating patients undergoing donor stem cell transplant for hematologic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
Primary
- Test the effects of a Standardized Nursing Intervention Protocol (SNIP) on overall quality of life (QOL); physical, psychological, social, and spiritual well-being subscales; and functional status of patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT) at discharge, 3, 6, and 12 months post-hospitalization as compared to AHSCT patients who receive the usual care and attention control.
Secondary
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Test the effects of SNIP-AHSCT on time-to-first complication, total number of complications, and mortality across these groups of patients.
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Identify subgroups of patients who benefit most from the SNIP-AHSCT in relation to sociodemographic characteristics, disease and clinical factors, and transplant factors.
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Decompose the effect of the SNIP-AHSCT on QOL into direct and indirect effects.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
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Group 1: Patients receive home teaching visits on medical aspects of self care, monitor and respond to signs and symptoms of infections, recommended exercise and nutrition program, relevant literature on bone marrow transplantation, diet, nutrition, and a variety of resources at 1, 2, and 3 months after hospital discharge. Patients also receive telephone-reinforcement calls monthly in months 4-12, and have a 24-hour telephone availability throughout the study. Patients complete the City of Hope quality of life questionnaires on physical, psychological, social, and spiritual well-being, and physical functional status at discharge, and then at 3, 6, and 12 months after hospitalization.
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Group 2: Patients receive usual medical care and attention at discharge, and then at 3, 6, and 12 months after hospitalization. Patients also have a hot-line availability throughout the study.
Study Design
Outcome Measures
Primary Outcome Measures
- Overall quality of life (physical, psychological, social, and spiritual well-being) [Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline]
- Functional status [Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline]
Secondary Outcome Measures
- Time-to-first complication [Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline]
- Total number of complications [Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline]
- Mortality [Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of a hematologic cancer (e.g., leukemia or lymphoma)
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Scheduled for a single allogeneic bone marrow or peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
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Living within a 50-mile radius of the City of Hope National Medical Center
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English-speaking
PRIOR CONCURRENT THERAPY:
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See Disease Characteristics
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No prior hematopoietic stem cell transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Marcia Grant, RN, DNSc, FAAN, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05081
- R01CA107446
- P30CA033572
- CHNMC-05081
- CDR0000643265