Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
This study is ongoing, but not recruiting participants.
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Christine Rini, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00701844
First received: June 4, 2008
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
The Sharing Our Strength study is being conducted to help us understand people's experiences with hematopoietic stem cell transplantation and to test a new program designed to help people recover physically and emotionally after transplant.
| Condition | Intervention |
|---|---|
|
Leukemia Acute Leukemia Acute Lymphocytic Leukemia Multiple Myeloma Hematological Cancers Psychological Distress |
Behavioral: Writing A (Experimental informative writing) Behavioral: Writing B (Experimental noninformative writing) Behavioral: Writing C (Control informative writing) Behavioral: Writing D (Control noninformative writing) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors |
Resource links provided by NLM:
MedlinePlus related topics:
Anemia
Cancer
Chronic Lymphocytic Leukemia
Leukemia
Lymphatic Diseases
Lymphoma
Multiple Myeloma
U.S. FDA Resources
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Psychological Adjustment [ Time Frame: At screening, baseline and 3 months following intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: At screening, baseline and 3 months following intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Experimental Writing Type 1 |
Behavioral: Writing A (Experimental informative writing)
Experimental informative writing
|
| Experimental: Experimental Writing type 2 |
Behavioral: Writing B (Experimental noninformative writing)
Experimental noninformative writing
|
| Active Comparator: Control writing type 1 |
Behavioral: Writing C (Control informative writing)
Control informative writing
|
| Placebo Comparator: Control writing type 2 |
Behavioral: Writing D (Control noninformative writing)
Control noninformative writing
|
Detailed Description:
This is a study for survivors of hematopoietic stem cell transplantation (also known as bone marrow transplant), which is an intensive medical treatment for cancers such as leukemia, lymphoma, and multiple myeloma as well as other diseases. Because it is a physically and emotionally demanding treatment, many people report having ongoing physical and emotional difficulties after having a transplant. The Sharing Our Strength study is being conducted to help us understand people's transplant experiences and to test a new program designed to help them recover physically and emotionally after transplant. All parts of the study are completed by mail and telephone. Participants will receive compensation for their time.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be a transplant survivor who is 9 months to 3 years beyond transplant and not currently relapsed. and not currently relapsed
- Be at least 18 years old now (and at least 16 when they had their transplant)
- Speak English
- Have telephone service
Exclusion Criteria:
- None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701844
Locations
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601-1991 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-6011 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
American Cancer Society, Inc.
Investigators
| Principal Investigator: | Christine Rini, Ph.D. | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Christine Rini, PhD, Research Associate Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00701844 History of Changes |
| Other Study ID Numbers: | GCO #06-0391 (2), RSGPB-07-285-01-CPPB |
| Study First Received: | June 4, 2008 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Aplastic Anemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Anemia Quality of Life Aplastic anemia Lymphoproliferative Disorders Lymphoma Multiple Myeloma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 16, 2013