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

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00701844

Collaborator

American Cancer Society, Inc. (Other)

315

Enrollment

Locations

Arms

Duration (Months)

105

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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 Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Psychological Adjustment [At screening, baseline and 3 months following intervention]

Secondary Outcome Measures

Quality of Life [At screening, baseline and 3 months following intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601-1991
2	Mount Sinai School of Medicine	New York	New York	United States	10029
3	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-6011