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

NCT ID: NCT00701844

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Leukemia Acute Leukemia Acute Lymphocytic Leukemia Multiple Myeloma Hematological Cancers Psychological Distress

Keywords

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Aplastic Anemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Anemia Quality of Life Lymphoproliferative Disorders Lymphoma Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental Writing Type 1

Group Type EXPERIMENTAL

Writing A (Experimental informative writing)

Intervention Type BEHAVIORAL

Experimental informative writing

Experimental Writing type 2

Group Type EXPERIMENTAL

Writing B (Experimental noninformative writing)

Intervention Type BEHAVIORAL

Experimental noninformative writing

Control writing type 1

Group Type ACTIVE_COMPARATOR

Writing C (Control informative writing)

Intervention Type BEHAVIORAL

Control informative writing

Control writing type 2

Group Type PLACEBO_COMPARATOR

Writing D (Control noninformative writing)

Intervention Type BEHAVIORAL

Control noninformative writing

Interventions

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Writing A (Experimental informative writing)

Experimental informative writing

Intervention Type BEHAVIORAL

Writing B (Experimental noninformative writing)

Experimental noninformative writing

Intervention Type BEHAVIORAL

Writing C (Control informative writing)

Control informative writing

Intervention Type BEHAVIORAL

Writing D (Control noninformative writing)

Control noninformative writing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine Rini, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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RSGPB-07-285-01-CPPB

Identifier Type: OTHER

Identifier Source: secondary_id

GCO #06-0391 (2)

Identifier Type: -

Identifier Source: org_study_id