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A Standardized Nursing Intervention Protocol for HCT Patients

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ClinicalTrials.gov Identifier: NCT00951626
Recruitment Status : Completed
First Posted : August 4, 2009
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
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 Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Standardized Nursing Intervention Protocol for HCT Patients
Study Start Date : September 2005
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Functional status [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ]

Secondary Outcome Measures :
  1. Time-to-first complication [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ]
  2. Total number of complications [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ]
  3. Mortality [ Time Frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00951626


Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marcia Grant, RN, DNSc, FAAN City of Hope Comprehensive Cancer Center
More Information
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00951626    
Other Study ID Numbers: 05081
R01CA107446 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-05081
CDR0000643265 ( Registry Identifier: NCI PDQ )
First Posted: August 4, 2009    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
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:
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Lymphoma
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Plasmacytoma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions