- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00701844
Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
November 14, 2017 updated by: University of North Carolina, Chapel Hill
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
315
Phase
- Not Applicable
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
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601-1991
- Hackensack University Medical Center
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai School of Medicine
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-6011
- University of North Carolina at Chapel Hill
-
-
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
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Writing Type 1
|
Experimental informative writing
|
Experimental: Experimental Writing type 2
|
Experimental noninformative writing
|
Active Comparator: Control writing type 1
|
Control informative writing
|
Placebo Comparator: Control writing type 2
|
Control noninformative writing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychological Adjustment
Time Frame: At screening, baseline and 3 months following intervention
|
At screening, baseline and 3 months following intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: At screening, baseline and 3 months following intervention
|
At screening, baseline and 3 months following intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christine Rini, Ph.D., Icahn School of Medicine at Mount Sinai
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
July 1, 2007
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 18, 2008
First Posted (Estimate)
June 19, 2008
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 14, 2017
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia, Lymphoid
- Multiple Myeloma
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
Other Study ID Numbers
- GCO #06-0391 (2)
- RSGPB-07-285-01-CPPB (Other Identifier: American Cancer Society)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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