A Standardized Nursing Intervention Protocol for HCT Patients

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.

Conditions

• 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

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Marcia Grant, RN, DNSc, FAAN · City of Hope Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• United States

Study Locations