LeukemiaNCT00701844
Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
A study testing Writing A (Experimental informative writing) and Writing B (Experimental noninformative writing) in people with Leukemia and Acute Leukemia, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Acute Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- Writing A (Experimental informative writing) and Writing B (Experimental noninformative writing)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-6011
Hackensack University Medical Center
Hackensack, New Jersey, 07601-1991
Mount Sinai School of Medicine
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Leukemia, Acute Leukemia, Acute Lymphocytic Leukemia, Multiple Myeloma, Hematological Cancers, Psychological Distress
- Being tested
- Writing A (Experimental informative writing), Writing B (Experimental noninformative writing), Writing C (Control informative writing), Writing D (Control noninformative writing)
- Keywords
- Aplastic Anemia, Lymphatic Diseases, Leukemia, Leukemia, Lymphoid, Immunoproliferative Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Anemia, Quality of Life, Lymphoproliferative Disorders, Lymphoma, Multiple Myeloma
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Multiple Myeloma, Anemia, Aplastic, Lymphatic Diseases, Leukemia, Lymphoid, Immunoproliferative Disorders, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing A (Experimental informative writing)Behavioural
Experimental informative writing
Writing B (Experimental noninformative writing)Behavioural
Experimental noninformative writing
Writing C (Control informative writing)Behavioural
Control informative writing
Writing D (Control noninformative writing)Behavioural
Control noninformative writing
| Study group | Role | What they receive |
|---|---|---|
| Experimental Writing Type 1 | Experimental | Not described Receives: Behavioral: Writing A (Experimental informative writing) |
| Experimental Writing type 2 | Experimental | Not described Receives: Behavioral: Writing B (Experimental noninformative writing) |
| Control writing type 1 | Active comparator | Not described Receives: Behavioral: Writing C (Control informative writing) |
| Control writing type 2 | Placebo comparator | Not described Receives: Behavioral: Writing D (Control noninformative writing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Adjustment
Measured: At screening, baseline and 3 months following intervention
Secondary outcomes (1)
Quality of Life
Measured: At screening, baseline and 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Christine Rini, Ph.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701844
- Sponsor's protocol ID
- GCO #06-0391 (2)
- Other IDs
- RSGPB-07-285-01-CPPB
- Status last verified
- May 2013
- First submitted
- 4 Jun 2008
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharing Our Strength: A Research Study for Bone Marrow/Stem Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT00701844
- Acronym / sponsor ID
- GCO #06-0391 (2)
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Jul 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Writing A (Experimental informative writing)Experimental informative writing | Behavioural | Experimental Writing Type 1 |
| Writing B (Experimental noninformative writing)Experimental noninformative writing | Behavioural | Experimental Writing type 2 |
| Writing C (Control informative writing)Control informative writing | Behavioural | Control writing type 1 |
| Writing D (Control noninformative writing)Control noninformative writing | Behavioural | Control writing type 2 |
Primary outcome
Psychological Adjustment
Time frame: At screening, baseline and 3 months following intervention
1 secondary outcome
Quality of Life
Time frame: At screening, baseline and 3 months following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Rini, Ph.D. principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Writing A (Experimental informative writing) and Writing B (Experimental noninformative writing) in people with Leukemia and Acute Leukemia, run by University of North Carolina, Chapel Hill at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Adjustment (time frame: At screening, baseline and 3 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 28 Oct 2026.