A Standardized Nursing Intervention Protocol for HCT Patients
5 other identifiers
interventional
282
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 8, 2015
June 1, 2015
6 years
August 1, 2009
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Functional status
Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Secondary Outcomes (3)
Time-to-first complication
Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Total number of complications
Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Mortality
Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Interventions
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.
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.
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.
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.
For both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant.
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
Collected throughout the 12 month study period
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
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.
For both groups of participants, questionnaires administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital 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. Also the Intervention Nurse will be available by phone or email within 48 hours of request for 100 days post transplant.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcia Grant, RN, DNSc, FAAN
City of Hope Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2009
First Posted
August 4, 2009
Study Start
September 1, 2005
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
June 8, 2015
Record last verified: 2015-06