Chronic Myeloproliferative DisordersNCT00951626
A Standardized Nursing Intervention Protocol for HCT Patients
A study testing exercise intervention, telephone-based intervention and dietary intervention in people with Chronic Myeloproliferative Disorders and Leukemia, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- exercise intervention, telephone-based intervention and dietary intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
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.
Read the 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.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- exercise intervention, telephone-based intervention, dietary intervention, educational intervention, questionnaire administration
- Keywords
- 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
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
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 interventionBehavioural
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 interventionDietary 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 interventionOther
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 administrationOther
For both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge.
allogeneic bone marrow transplantationProcedure or surgery
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant.
allogeneic hematopoietic stem cell transplantationProcedure or surgery
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
assessment of therapy complicationsProcedure or surgery
Collected throughout the 12 month study period
peripheral blood stem cell transplantationProcedure or surgery
Patient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant.
psychosocial assessment and careProcedure or surgery
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 assessmentProcedure or surgery
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 careProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall quality of life (physical, psychological, social, and spiritual well-being)
Measured: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Functional status
Measured: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Secondary outcomes (3)
Time-to-first complication
Measured: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Total number of complications
Measured: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Mortality
Measured: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startSep 2005
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marcia Grant, RN, DNSc, FAAN, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951626
- Sponsor's protocol ID
- 05081
- Other IDs
- R01CA107446, P30CA033572, CHNMC-05081, CDR0000643265
- Status last verified
- Jun 2015
- First submitted
- 1 Aug 2009
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Nursing Intervention Protocol for HCT Patients
- ClinicalTrials.gov ID
- NCT00951626
- Acronym / sponsor ID
- 05081
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise interventionThose 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. | Behavioural | – |
| telephone-based interventionThose 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. | Behavioural | – |
| dietary interventionThose 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. | Dietary supplement | – |
| educational interventionThose 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 administrationFor both groups of participants, administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge. | Other | – |
| allogeneic bone marrow transplantationPatient with a diagnosis of a hematologic cancer scheduled for a single allogeneic bone marrow transplant. | Procedure or surgery | – |
| allogeneic hematopoietic stem cell transplantationPatient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant. | Procedure or surgery | – |
| assessment of therapy complicationsCollected throughout the 12 month study period | Procedure or surgery | – |
| peripheral blood stem cell transplantationPatient with a diagnosis of a hematologic cancer scheduled for a single allogeneic stem cell transplant. | Procedure or surgery | – |
| psychosocial assessment and careThose 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 or surgery | – |
| quality-of-life assessmentFor both groups of participants, questionnaires administered at baseline (prior to hospital discharge and 3, 6, and 12 months post hospital discharge. | Procedure or surgery | – |
| standard follow-up careThose 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. | Procedure or surgery | – |
Primary outcome
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
Functional status
Time frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
3 secondary outcomes
Time-to-first complication
Time frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Total number of complications
Time frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Mortality
Time frame: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Grant, RN, DNSc, FAAN principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, telephone-based intervention and dietary intervention in people with Chronic Myeloproliferative Disorders and Leukemia, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2015.