Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caregiver Support in the Quality of Life of Patients Who Are Undergoing Donor Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281801
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

RATIONALE: Questionnaires that measure quality-of-life may improve the health care team's ability to plan supportive care for patients undergoing donor bone marrow transplantation.

PURPOSE: This clinical trial is studying quality of life in patients who are undergoing donor bone marrow transplantation.


Condition or disease Intervention/treatment
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Psychosocial Effects of Cancer and Its Treatment Procedure: psychosocial assessment and care Procedure: Quality of Life Assessments

Detailed Description:

OBJECTIVES:

  • Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation.

OUTLINE: Patients complete a 30-minute quality of life questionnaire in order to measure their psychosocial health while in the bone marrow transplant program, including Functional Assessment of Cancer Therapy (FACT), Profile of Mood State (POMS), and Brief COPE questionnaires, at the baseline (pre-transplant) appointment, at the first physician's visit after discharge, at day 100 post-transplant, and then at 6 months and 1 year post-transplant. Caregivers complete a 30-minute coping questionnaire at the pre-transplant appointment, at the first physician's visit after discharge, and then at day 100 post-transplant. Caregivers also keep a weekly log of the time spent with the patient in the hospital.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Survival in Allogeneic Bone Marrow Transplantation: The Relative Importance of Inpatient Lay Care-Partner Support
Study Start Date : February 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: psychosocial assessment and care
    psychosocial assessment and care
  • Procedure: Quality of Life Assessments
    PACT Scale, Brief COPE, POMS Short Form and FACT BMT

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlate presence of a lay care-partner with survival post transplant [ Time Frame: At least one year post transplant ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Allogeneic Bone Marrow Transplant patients with lay care-partners.
Criteria

DISEASE CHARACTERISTICS:

  • Must be a candidate for allogeneic unrelated or related stem cell transplantation

PATIENT CHARACTERISTICS:

  • Both patient and lay care-partner must have the ability to understand and the willingness to sign a written informed consent document

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00281801


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00281801    
Other Study ID Numbers: CCF6330
P30CA043703 ( U.S. NIH Grant/Contract )
CCF-6330 ( Other Identifier: Cleveland Clinic IRB )
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by Case Comprehensive Cancer Center:
psychosocial effects of cancer and its treatment
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
 extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Neoplasms
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