Trials / Completed

CompletedNCT00951626

A Standardized Nursing Intervention Protocol for HCT Patients

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 282 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

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 * 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.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	exercise intervention	Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge. Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge.
BEHAVIORAL	telephone-based intervention	Those on the Standard Nursing Intervention Program will receive phone calls from the Intervention Nurse after the first 3 months and then monthly calls up to 12 months post hospital discharge. For those on the Usual Care plus Attention Control program, the Intervention Nurse will be available by phone or email within 48 hours of request for 100 days post transplant.
DIETARY_SUPPLEMENT	dietary intervention	Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge. Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge.
OTHER	educational intervention	Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge. Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge.
OTHER	questionnaire administration	For both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
PROCEDURE	allogeneic bone marrow transplantation	Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant.
PROCEDURE	allogeneic hematopoietic stem cell transplantation	Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
PROCEDURE	assessment of therapy complications	Collected throughout the 12 month study period
PROCEDURE	peripheral blood stem cell transplantation	Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
PROCEDURE	psychosocial assessment and care	Those on the Standard Nursing Intervention Program will be offered six educational sessions spaced over the first 3 months after discharge. They will also receive phone calls from the Intervention Nurse after the first 3 months and then monthly calls up to 12 months post hospital discharge.
PROCEDURE	quality-of-life assessment	For both groups of participants, questionnaires administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
PROCEDURE	standard follow-up care	Those on the Usual Care plus Attention Control program will be offered a copy of the complete teaching manual for Hematopoietic Cell Transplant patients which will stay with them during hospitalization and be sent home after discharge. Also the Intervention Nurse will be available by phone or email within 48 hours of request for 100 days post transplant.

Timeline

Start date: 2005-09-01
Primary completion: 2011-09-01
Completion: 2011-09-01
First posted: 2009-08-04
Last updated: 2015-06-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00951626. Inclusion in this directory is not an endorsement.