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

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00281801
Collaborator
National Cancer Institute (NCI) (NIH)
168
1
49.9
3.4

Study Details

Study Description

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 Phase
  • 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

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 :
Feb 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Apr 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Correlate presence of a lay care-partner with survival post transplant [At least one year post transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

  • Study Chair: Brian J. Bolwell, MD, Cleveland Clinic Taussig Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00281801
Other Study ID Numbers:
  • CCF6330
  • P30CA043703
  • CCF-6330
First Posted:
Jan 25, 2006
Last Update Posted:
Mar 15, 2012
Last Verified:
Mar 1, 2012
Keywords provided by Case Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2012