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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00281801
First received: January 24, 2006
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Survival in Allogeneic Bone Marrow Transplantation: The Relative Importance of Inpatient Lay Care-Partner Support

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Correlate presence of a lay care-partner with survival post transplant [ Time Frame: At least one year post transplant ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: February 2006
Study Completion Date: April 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281801

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00281801     History of Changes
Other Study ID Numbers: CCF6330, P30CA043703, CCF-6330
Study First Received: January 24, 2006
Last Updated: March 13, 2012
Health Authority: United States: Institutional Review Board

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:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Syndrome
Plasmacytoma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014