NCT00701844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable leukemia

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable leukemia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 17, 2017

Status Verified

May 1, 2013

Enrollment Period

4.2 years

First QC Date

June 4, 2008

Last Update Submit

November 14, 2017

Conditions

Keywords

Aplastic AnemiaLymphatic DiseasesLeukemiaLeukemia, LymphoidImmunoproliferative DisordersPrecursor Cell Lymphoblastic Leukemia-LymphomaAnemiaQuality of LifeLymphoproliferative DisordersLymphomaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Psychological Adjustment

    At screening, baseline and 3 months following intervention

Secondary Outcomes (1)

  • Quality of Life

    At screening, baseline and 3 months following intervention

Study Arms (4)

Experimental Writing Type 1

EXPERIMENTAL
Behavioral: Writing A (Experimental informative writing)

Experimental Writing type 2

EXPERIMENTAL
Behavioral: Writing B (Experimental noninformative writing)

Control writing type 1

ACTIVE COMPARATOR
Behavioral: Writing C (Control informative writing)

Control writing type 2

PLACEBO COMPARATOR
Behavioral: Writing D (Control noninformative writing)

Interventions

Experimental informative writing

Experimental Writing Type 1

Experimental noninformative writing

Experimental Writing type 2

Control informative writing

Control writing type 1

Control noninformative writing

Control writing type 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hackensack University Medical Center

Hackensack, New Jersey, 07601-1991, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-6011, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaMultiple MyelomaAnemia, AplasticLymphatic DiseasesLeukemia, LymphoidImmunoproliferative DisordersAnemiaLymphoproliferative DisordersLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow Failure DisordersBone Marrow Diseases

Study Officials

  • Christine Rini, Ph.D.

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2008

First Posted

June 19, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 17, 2017

Record last verified: 2013-05

Locations