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

November 14, 2017 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-1991
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-6011
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychological Adjustment
Time Frame: At screening, baseline and 3 months following intervention
At screening, baseline and 3 months following intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: At screening, baseline and 3 months following intervention
At screening, baseline and 3 months following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Christine Rini, Ph.D., Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO #06-0391 (2)
  • RSGPB-07-285-01-CPPB (Other Identifier: American Cancer Society)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Clinical Trials on Writing A (Experimental informative writing)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe