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

Lymphoma Clinical Trial

Official title:

Survival in Allogeneic Bone Marrow Transplantation: The Relative Importance of Inpatient Lay Care-Partner Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281801
• Other study ID #: CCF6330
• Secondary ID: P30CA043703CCF-6
• Status: Completed
• Phase: N/A
• First received: January 24, 2006
• Last updated: March 13, 2012
• Start date: February 2006
• Est. completion date: April 2010

Study information

• Verified date: March 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• psychosocial assessment and care
psychosocial assessment and care
• Quality of Life Assessments
PACT Scale, Brief COPE, POMS Short Form and FACT BMT

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate presence of a lay care-partner with survival post transplant		At least one year post transplant	No