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

Primary Purpose

Leukemia, Acute Leukemia, Acute Lymphocytic Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Writing A (Experimental informative writing)
Writing B (Experimental noninformative writing)
Writing C (Control informative writing)
Writing D (Control noninformative writing)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Aplastic Anemia, Lymphatic Diseases, Leukemia, Leukemia, Lymphoid, Immunoproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Quality of Life, Lymphoproliferative Disorders, Lymphoma, Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hackensack University Medical Center
  • Mount Sinai School of Medicine
  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental Writing Type 1

Experimental Writing type 2

Control writing type 1

Control writing type 2

Arm Description

Outcomes

Primary Outcome Measures

Psychological Adjustment

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
June 4, 2008
Last Updated
November 14, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00701844
Brief Title
Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
Official Title
Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Acute Leukemia, Acute Lymphocytic Leukemia, Multiple Myeloma, Hematological Cancers, Psychological Distress
Keywords
Aplastic Anemia, Lymphatic Diseases, Leukemia, Leukemia, Lymphoid, Immunoproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Quality of Life, Lymphoproliferative Disorders, Lymphoma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Writing Type 1
Arm Type
Experimental
Arm Title
Experimental Writing type 2
Arm Type
Experimental
Arm Title
Control writing type 1
Arm Type
Active Comparator
Arm Title
Control writing type 2
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Writing A (Experimental informative writing)
Intervention Description
Experimental informative writing
Intervention Type
Behavioral
Intervention Name(s)
Writing B (Experimental noninformative writing)
Intervention Description
Experimental noninformative writing
Intervention Type
Behavioral
Intervention Name(s)
Writing C (Control informative writing)
Intervention Description
Control informative writing
Intervention Type
Behavioral
Intervention Name(s)
Writing D (Control noninformative writing)
Intervention Description
Control noninformative writing
Primary Outcome Measure Information:
Title
Psychological Adjustment
Time Frame
At screening, baseline and 3 months following intervention
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
At screening, baseline and 3 months following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Rini, Ph.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1991
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-6011
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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