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

March 13, 2012 updated by: Case Comprehensive Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Allogeneic Bone Marrow Transplant patients with lay care-partners.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlate presence of a lay care-partner with survival post transplant Time Frame: At least one year post transplant	At least one year post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria