Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Caregiver Support in the Coping of Patients Who Are Undergoing a Donor Bone Marrow Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00281814
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Navneet Majhail, MD, The Cleveland Clinic

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
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

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adjustment to Illness by Survival Rates in Allogeneic Bone Marrow Transplant (BMT): The Relative Importance of Lay Care-Partner Support
Actual Study Start Date : February 1, 2006
Actual Primary Completion Date : December 31, 2008
Actual Study Completion Date : January 4, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: psychosocial assessment and care
    psychosocial assessment and care

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Compare modes of illness adjustment, presence or absence of an inpatient lay care-partner, and survival rates [ Time Frame: Through 100 days post transplant ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Local patients receiving allogeneic bone marrow transplant.
Criteria

DISEASE CHARACTERISTICS:

  • Medically suitable for allogeneic bone marrow transplantation

PATIENT CHARACTERISTICS:

  • Resides locally in the Cleveland, Ohio area

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281814


Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Navneet Majhail, MD, Director Blood & Marrow Transplant Program, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00281814    
Other Study ID Numbers: CASE-CCF-6950
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CCF-6950
CASE-CCF-1035
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Navneet Majhail, MD, The Cleveland Clinic:
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
de novo myelodysplastic syndromes
 extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions