Hematopoietic Stem Cell Transplantation09-SQOLNCT01353677
Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
An observational study of Hematopoietic Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 7 sites in United States.
Trial summary
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- How many people
- 390 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2011to 30 Oct 2014
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult allogeneic HCT recipients
Who may be able to join
- Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
- Signed informed consent form from adult patient or parent/guardian of pediatric patient.
- Patient must have a valid mailing address within the United States to receive QOL surveys.
- Ability to speak and read English.
- Patients with access to a telephone.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
University of Florida
Gainesville, Florida, 32610
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.
Read the detailed description
QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Hematopoietic stem cell transplantation, QOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HSCT recipients | 1. Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. 2. Signed informed consent form from adult patient or parent/guardian of pediatric patient. 3. Patient must have a valid mailing address within the United States to receive QOL surveys. 4. Ability to speak and read English. 5. Patients with access to a telephone. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJul 2011
- Primary completion30 Oct 2014
- Study completion30 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Douglas Rizzo, MD, MS, Principal investigator, CIBMTR/ Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353677
- Sponsor's protocol ID
- 09-SQOL
- Acronym
- 09-SQOL
- Status last verified
- Jul 2017
- First submitted
- 12 May 2011
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
- ClinicalTrials.gov ID
- NCT01353677
- Acronym / sponsor ID
- 09-SQOL / 09-SQOL
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Hematopoietic stem cell transplantation, QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- Medical College of Wisconsin
- Study start
- Jul 2011 (actual)
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 30 Oct 2014 (actual)
- First posted
- 16 May 2011 (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.
This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.
Detailed description
QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSCT recipients | – | –1. Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers. 2. Signed informed consent form from adult patient or parent/guardian of pediatric patient. 3. Patient must have a valid mailing address within the United States to receive QOL surveys. 4. Ability to speak and read English. 5. Patients with access to a telephone. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult allogeneic HCT recipients
Key inclusion criteria (5 listed)
- Adult (≥ 18 years), or pediatric (≥ 2 years and < 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
- Signed informed consent form from adult patient or parent/guardian of pediatric patient.
- Patient must have a valid mailing address within the United States to receive QOL surveys.
- Ability to speak and read English.
- Patients with access to a telephone.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 25 Jul 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.
Douglas Rizzo, MD, MS principal investigator
CIBMTR/ Medical College of Wisconsin
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation, run by Center for International Blood and Marrow Transplant Research at 7 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 5 inclusion and 0 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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.
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 25 Jul 2017.