A Standardized Nursing Intervention Protocol for HCT Patients

City of Hope

Status

Completed

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Chronic Myeloproliferative Disorders

Therapy-related Toxicity

Psychosocial Effects of Cancer and Its Treatment

Lymphoma

Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasms

Treatments

Behavioral: exercise intervention

Other: educational intervention

Dietary Supplement: dietary intervention

Other: questionnaire administration

Procedure: standard follow-up care

Procedure: peripheral blood stem cell transplantation

Behavioral: telephone-based intervention

Procedure: psychosocial assessment and care

Procedure: assessment of therapy complications

Procedure: allogeneic bone marrow transplantation

Procedure: allogeneic hematopoietic stem cell transplantation

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00951626

05081

P30CA033572 (U.S. NIH Grant/Contract)

R01CA107446 (U.S. NIH Grant/Contract)

CDR0000643265 (Registry Identifier)

CHNMC-05081

Details and patient eligibility

About

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.

Full 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

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.

Enrollment

282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: