Hematopoietic Stem Cell TransplantNCT01504152
International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center
An observational study of Hematopoietic Stem Cell Transplant, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to survey patients who underwent hematopoietic stem cell transplant (HSCT) to assess if they have traveled or not internationally after transplant. This information will help to improve the understanding of the needs for travel health strategies and interventions to provide healthy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 519 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received HSCT at MSKCC between 2005-2010 and were alive after the first year after HSCT.
Who may be able to join
- Hematopoietic Stem Cell Transplant (HSCT) recipients at MSKCC from 1/1/2005 to 12/31/2010.
- Age at HSCT ≥ 18 years
- Permanent mailing address in the United States of America
Who cannot join
- Subject unable to fill the questionnaire due to language barriers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Survey to Assess International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center
The purpose of this study is to survey patients who underwent hematopoietic stem cell transplant (HSCT) to assess if they have traveled or not internationally after transplant. This information will help to improve the understanding of the needs for travel health strategies and interventions to provide healthy and safe travel to HSCT patients. The findings of this survey will also be used to develop travel health related interventions for patients living with cancer as well.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- questionnaire
- Keywords
- International travel, cancer patients, HSCT, Quality of Life, questionnaire, 11-176
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireBehavioural
The intervention is a self-administered questionnaire that is voluntarily completed by the subject. This questionnaire has been previously validated and demonstrated to be reproducible in English speaking travelers. The final version of the survey questionnaire consists of 49 questions.Patients who never traveled after HSCT will answer only eighteen questions related to their medical and HSCT history in addition to their demographics.
| Study group | Role | What they receive |
|---|---|---|
| patients who received HSCT at MSKCC between 2005-2010 | A self-administered patient questionnaire will be used to collect data that will assess the prevalence of international travel after HSCT and travel related morbidity and exposure risks among HSCT recipients. Receives: Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of international travel
of the targeted patients Proportion of Hematopoietic Stem Cell Transplant (HSCT) patients who traveled internationally within two years after HSCT
Measured: 2 years
Secondary outcomes (3)
international travel was during a high-risk specific period
Proportion of patients traveling to destinations that are at high risk areas for infections
Measured: 2 years
patients that sought pre-travel health advice
among those who traveled to high risk areas for infections
Measured: 2 years
travelers that becomes ill and required medical attention
during or after return from international travel.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 519 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Monika Shah, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504152
- Sponsor's protocol ID
- 11-176
- Status last verified
- Jul 2013
- First submitted
- 3 Jan 2012
- Last updated
- 12 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey to Assess International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center
- ClinicalTrials.gov ID
- NCT01504152
- Acronym / sponsor ID
- 11-176
- Conditions
- Hematopoietic Stem Cell Transplant
- Keywords
- International travel, cancer patients, HSCT, Quality of Life, questionnaire, 11-176
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Jan 2012 (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 purpose of this study is to survey patients who underwent hematopoietic stem cell transplant (HSCT) to assess if they have traveled or not internationally after transplant. This information will help to improve the understanding of the needs for travel health strategies and interventions to provide healthy and safe travel to HSCT patients. The findings of this survey will also be used to develop travel health related interventions for patients living with cancer as well.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who received HSCT at MSKCC between 2005-2010 | – | Behavioral: questionnaireA self-administered patient questionnaire will be used to collect data that will assess the prevalence of international travel after HSCT and travel related morbidity and exposure risks among HSCT recipients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received HSCT at MSKCC between 2005-2010 and were alive after the first year after HSCT.
Key inclusion criteria (3 listed)
- Hematopoietic Stem Cell Transplant (HSCT) recipients at MSKCC from 1/1/2005 to 12/31/2010.
- Age at HSCT ≥ 18 years
- Permanent mailing address in the United States of America
Key exclusion criteria (1 listed)
- Subject unable to fill the questionnaire due to language barriers.
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 |
|---|---|---|
| questionnaireThe intervention is a self-administered questionnaire that is voluntarily completed by the subject. This questionnaire has been previously validated and demonstrated to be reproducible in English speaking travelers. The final version of the survey questionnaire consists of 49 questions.Patients who never traveled after HSCT will answer only eighteen questions related to their medical and HSCT history in addition to their demographics. | Behavioural | patients who received HSCT at MSKCC between 2005-2010 |
Primary outcome
prevalence of international travel
Time frame: 2 years
of the targeted patients Proportion of Hematopoietic Stem Cell Transplant (HSCT) patients who traveled internationally within two years after HSCT
3 secondary outcomes
international travel was during a high-risk specific period
Time frame: 2 years
patients that sought pre-travel health advice
Time frame: 2 years
travelers that becomes ill and required medical attention
Time frame: 2 years
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 12 Jul 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Monika Shah, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site 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 Transplant, run by Memorial Sloan Kettering Cancer Center at 1 site 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 3 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 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
prevalence of international travel (time frame: 2 years). 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 12 Jul 2013.