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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
History of Changes

January 24, 2006
March 13, 2012
February 2006
December 2008   (final data collection date for primary outcome measure)
Correlate presence of a lay care-partner with survival post transplant [ Time Frame: At least one year post transplant ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00281801 on ClinicalTrials.gov Archive Site
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Caregiver Support in the Quality of Life of Patients Who Are Undergoing Donor Bone Marrow Transplantation
Survival in Allogeneic Bone Marrow Transplantation: The Relative Importance of Inpatient Lay Care-Partner Support

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Allogeneic Bone Marrow Transplant patients with lay care-partners.
  • 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
    psychosocial assessment and care
  • Procedure: Quality of Life Assessments
    PACT Scale, Brief COPE, POMS Short Form and FACT BMT
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
April 2010
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00281801
CCF6330, P30CA043703, CCF-6330
No
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
Case Comprehensive Cancer Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP