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Completed

NCT Number: NCT00951626

A Standardized Nursing Intervention Protocol for HCT Patients

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.

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Key information

Conditions

Chronic Myeloproliferative Disorders Blast Crisis Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Neutrophilic, Chronic Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasms Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Psychosocial Effects of Cancer and Its Treatment Sezary Syndrome Therapy-related Toxicity Tumor Virus Infections Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

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

Behavioral

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 intervention

Dietary Supplement

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.

Educational Intervention

Other

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

Other

For both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.

allogeneic bone marrow transplantation

Procedure

Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant.

allogeneic hematopoietic stem cell transplantation

Procedure

Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.

assessment of therapy complications

Procedure

Collected throughout the 12 month study period

peripheral blood stem cell transplantation

Procedure

Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.

psychosocial assessment and care

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2009
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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