Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors - Full Text View

Sponsors and Collaborators:	Mount Sinai School of Medicine American Cancer Society
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00701844

Purpose

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. To qualify they must:

Be a transplant survivor who is 9 months to 2 years beyond transplant and not currently relapsed
Are at least 18 years old now (and at least 16 when they had their transplant)
Speak English
Have telephone service

Condition	Intervention
Bone Marrow Transplantation Hematopoietic Stem Cell Transplantation Leukemia Acute Leukemia Acute Lymphocytic Leukemia Quality of Life 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)

MedlinePlus related topics: Bone Marrow Transplantation Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Factorial Assignment

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:

Psychological Adjustment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of Life [ Designated as safety issue: No ]

Estimated Enrollment:

350

Arms	Assigned Interventions
1: Experimental Writing A	Behavioral: Writing A (Experimental informative writing) Experimental informative writing
2: Experimental Writing B	Behavioral: Writing B (Experimental noninformative writing) Experimental noninformative writing
3: Active Comparator Writing C	Behavioral: Writing C (Control informative writing) Control informative writing
4 Writing D	Behavioral: Writing D (Control noninformative writing) Control noninformative writing

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 2 years beyond transplant 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

Contacts

Contact: Christine Rini, Ph.D.

212-659-5555

Christine.rini@mssm.edu

Locations

United States, New York
Mount Sinai School of Medcine	Recruiting
New York, New York, United States, 10029
Contact: Christine Rini, MD 212-659-5555 Christine.rini@mssm.edu
Principal Investigator: Marco Pappagallo, MD

Sponsors and Collaborators

Mount Sinai School of Medicine

American Cancer Society

Investigators

Principal Investigator:

Christine Rini, Ph.D.

Mount Sinai School of Medicine

More Information

Responsible Party:	Mount Sinai School of Medicine ( Christine Rini, Ph.D., Prinicipal Investigator )
Study ID Numbers:	GCO #06-0391, #RSGPB-07-285-01-CPPB
Study First Received:	June 4, 2008
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00701844
Health Authority:	United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:

aplastic anemia

Study placed in the following topic categories:

Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anemia, Aplastic

Anemia
Quality of Life
Aplastic anemia
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009