A Standardized Nursing Intervention Protocol for HCT Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00951626
First received: August 1, 2009
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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 Intervention
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
Behavioral: exercise intervention
Behavioral: telephone-based intervention
Dietary Supplement: dietary intervention
Other: educational intervention
Other: questionnaire administration
Procedure: allogeneic bone marrow transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: assessment of therapy complications
Procedure: peripheral blood stem cell transplantation
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: standard follow-up care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Standardized Nursing Intervention Protocol for HCT Patients

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Overall quality of life (physical, psychological, social, and spiritual well-being) [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-to-first complication [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ] [ Designated as safety issue: No ]
  • Total number of complications [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ] [ Designated as safety issue: No ]

Enrollment: 282
Study Start Date: September 2005
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951626

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Marcia Grant, RN, DNSc, FAAN Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00951626     History of Changes
Other Study ID Numbers: 05081, R01CA107446, P30CA033572, CHNMC-05081, CDR0000643265
Study First Received: August 1, 2009
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on April 23, 2014