Caregiver Support in the Coping of Patients Who Are Undergoing a Donor Bone Marrow Transplant
Official Title
Adjustment to Illness by Survival Rates in Allogeneic Bone Marrow Transplant (BMT): The Relative Importance of Lay Care-Partner Support
Acronym
Not provided
Organization
The Cleveland ClinicOTHER
Status Module
Record Verification Date
Jan 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2006Actual
Primary Completion Date
Dec 31, 2008Actual
Completion Date
Jan 4, 2017Actual
First Submitted Date
Jan 24, 2006
First Submission Date that Met QC Criteria
Jan 24, 2006
First Posted Date
Jan 25, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 25, 2018
Last Update Posted Date
Jan 26, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Navneet Majhail, MD, Director Blood & Marrow Transplant Program, The Cleveland ClinicPrincipal Investigator
Lead Sponsor
The Cleveland ClinicOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Questionnaires that measure coping may improve the ability to plan supportive care for patients undergoing donor bone marrow transplant.
PURPOSE: This clinical trial is studying coping in patients who are undergoing a donor bone marrow transplant.
Detailed Description
OBJECTIVES:
Investigate the relative importance of having a consistent inpatient lay care-partner for patients undergoing allogeneic bone marrow transplantation, in terms of the effects on modes of adjustment to illness and survival.
OUTLINE: Patients undergo a 40-minute recorded oral interview in person to provide personal and social demographic data using a 20-item questionnaire (The Adjustment to Illness Questionnaire-Bone Marrow Transplantation) at baseline (pre-transplant) and at day 100 post-transplant.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Psychosocial Effects of Cancer and Its Treatment
Keywords
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
36Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
psychosocial assessment and care
Procedure
psychosocial assessment and care
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Compare modes of illness adjustment, presence or absence of an inpatient lay care-partner, and survival rates
Through 100 days post transplant
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Medically suitable for allogeneic bone marrow transplantation
PATIENT CHARACTERISTICS:
Resides locally in the Cleveland, Ohio area
PRIOR CONCURRENT THERAPY:
Not specified
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Local patients receiving allogeneic bone marrow transplant.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Brian J. Bolwell, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland
Ohio
44195
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
de novo myelodysplastic syndromes
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue