Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
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: May 28, 2013
Last verified: May 2013
  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:


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 ]

Enrollment: 315
Study Start Date: July 2007
Study Completion Date: September 2011
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
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, see Learn About Clinical Studies.

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: May 28, 2013
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
Multiple Myeloma
Neoplasms, Plasma Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014