A Standardized Nursing Intervention Protocol for HCT Patients
18 Years
N/A
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Psychosocial Effects of Cancer and Its Treatment, Therapy-related Toxicity
Trial Information
A Standardized Nursing Intervention Protocol for HCT Patients
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
- Test the effects of SNIP-AHSCT on time-to-first complication, total number of
complications, and mortality across these groups of patients.
- Identify subgroups of patients who benefit most from the SNIP-AHSCT in relation to
sociodemographic characteristics, disease and clinical factors, and transplant factors.
- Decompose the effect of the SNIP-AHSCT on QOL into direct and indirect effects.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
- 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.
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of a hematologic cancer (e.g., leukemia or lymphoma)
- Scheduled for a single allogeneic bone marrow or peripheral blood stem cell
transplantation
PATIENT CHARACTERISTICS:
- Living within a 50-mile radius of the City of Hope National Medical Center
- English-speaking
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Outcome Measure:
Overall quality of life (physical, psychological, social, and spiritual well-being)
Outcome Time Frame:
Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Safety Issue:
No
Principal Investigator
Marcia Grant, RN, DNSc, FAAN
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Institutional Review Board
Study ID:
05081
NCT ID:
NCT00951626
Start Date:
September 2005
Completion Date:
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Psychosocial Effects of Cancer and Its Treatment
- Therapy-related Toxicity
- psychosocial effects of cancer and its treatment
- therapy-related toxicity
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic neutrophilic leukemia
- de novo myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- refractory multiple myeloma
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
