Caregiver Support in the Quality of Life of Patients Who Are Undergoing Donor Bone Marrow Transplantation
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| ClinicalTrials.gov Identifier: NCT00281801 |
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Recruitment Status :
Completed
First Posted : January 25, 2006
Last Update Posted : March 15, 2012
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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 |
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 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 |
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Procedure: psychosocial assessment and care
- Correlate presence of a lay care-partner with survival post transplant [ Time Frame: At least one year post transplant ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Study Chair: | Brian J. Bolwell, MD | Cleveland Clinic Taussig Cancer Institute |
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00281801 History of Changes |
| 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:
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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:
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Lymphoma Syndrome Leukemia Multiple Myeloma Neoplasms, Plasma Cell Myelodysplastic Syndromes Preleukemia Plasmacytoma Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases 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 |