A Standardized Nursing Intervention Protocol for HCT Patients

Lymphoma Clinical Trial

Official title:

A Standardized Nursing Intervention Protocol for HCT Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951626
• Other study ID #: 05081
• Secondary ID: R01CA107446P30CA
• Status: Completed
• Phase: N/A
• First received: August 1, 2009
• Last updated: June 3, 2015
• Start date: September 2005
• Est. completion date: September 2011

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Psychosocial Effects of Cancer and Its Treatment
• Therapy-related Toxicity

Intervention

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.
• 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.
• 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.
• allogeneic hematopoietic stem cell transplantation
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
• assessment of therapy complications
Collected throughout the 12 month study period
• peripheral blood stem cell transplantation
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Functional status		Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline	No
Secondary	Time-to-first complication		Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline	No
Secondary	Total number of complications		Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline	No
Secondary	Mortality		Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline	No