ClinicalTrials.gov
ClinicalTrials.gov Menu

Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors

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: NCT00701844
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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 or disease Intervention/treatment Phase
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) Not Applicable

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  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
Study Start Date : July 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Psychological Adjustment [ Time Frame: At screening, baseline and 3 months following intervention ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: At screening, baseline and 3 months following intervention ]


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


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): 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. Icahn School of Medicine at Mount Sinai

Responsible Party: 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 ( Other Identifier: American Cancer Society )
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: May 2013

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
Lymphoproliferative Disorders
Lymphoma
Multiple Myeloma

Additional relevant MeSH terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases