Breast CancerNCT01111201
International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients
An observational study of Breast Cancer and Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study also aims to raise awareness among both patients and health-care providers about the importance of pre-travel health consultation and preventive interventions prior to international travel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lymphoma
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2012
- 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: The goal accrual is 50 patients from each of the following oncology services: Breast, Lymphoma, Autologous Stem Cell Transplant, and Allogeneic Stem Cell Transplant.
Who may be able to join
- Hematopoietic Stem Cell Transplant (HSCT) recipients
- Age >18 years
- Status post bone marrow transplant within last five years Breast Cancer patients: Criteria 1 and Criteria 2 and/or 3
- Female age >18 years and current or past history of breast cancer
- Received systemic chemotherapy in the last five years
- Metastatic breast cancer disease (stage IV) Lymphoma: Criteria 1 and Criteria 2 and/or 3
Show all 9Show fewer
- Age >18 years and current or past history of lymphoma
- Received systemic chemotherapy within 5 years
- Had active disease at any time within the last 5 years
Who cannot join
- Patients age< 18 years
- Breast cancer and lymphoma patients in clinical remission in the past 5 years
- Patients 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: Pilot Survey to Assess International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients at Memorial Sloan-Kettering Cancer Center
This study also aims to raise awareness among both patients and health-care providers about the importance of pre-travel health consultation and preventive interventions prior to international travel.
Through appropriate health counseling, cancer patients will have less risk of having travel -related health complications and thus have a better quality of life and overall improved sense of wellbeing.
- Conditions
- Breast Cancer, Lymphoma
- Being tested
- questionnaires
- Keywords
- Autologous Bone Marrow Transplant, Breast, Lymphoma, International travel, questionnaire, Hematopoietic Stem Cell Transplant (HSCT) recipients
- Medical subject headings
- Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
The intervention is a self-administered anonymous questionnaire that is voluntarily completed by the patient. Questions in Section One will cover general information about the patient including gender, age, race, country of birth, current zip code of residence, and level of education. Questions in Section Two will cover information regarding the cancer (breast/lymphoma) or transplant (allogeneic/ autologous). Questions in Section Three will cover travel history including the frequency of travel outside the United States and Canada in the last 5 years. Questions in Sections Four through Seven will obtain information about their last trip outside the United States and Canada.
| Study group | Role | What they receive |
|---|---|---|
| questionnaires | There will be four versions of the questionnaire, each slightly modified to be more specific toward the treatment paradigms in the respective target patient population (Breast Cancer/ Lymphoma/Autologous Bone Marrow Transplant/ Allogeneic Bone Marrow Transplant). All questionnaire versions will consist of seven sections. Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the frequency of international travel of the targeted patients in the last 5 years.
Measured: once at the time of the clinic visit
Secondary outcomes (4)
To determine if any of the international travel was during a high-risk specific period when the immune status of the target population was compromised.
Measured: once at the time of the clinic visit
To profile the target population who traveled internationally with respect to their demographic and cancer/transplant-related characteristics.
Measured: once at the time of the clinic visit
To obtain detailed information about their last international trip including
Measured: once at the time of the clinic visit
To assess the adequacy of the questionnaire instructions
Measured: once at the time of the clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monika Shah, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111201
- Sponsor's protocol ID
- 10-045
- Status last verified
- May 2012
- First submitted
- 22 Apr 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Survey to Assess International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients at Memorial Sloan-Kettering Cancer Center
- ClinicalTrials.gov ID
- NCT01111201
- Acronym / sponsor ID
- 10-045
- Conditions
- Breast Cancer, Lymphoma
- Keywords
- Autologous Bone Marrow Transplant, Breast, Lymphoma, International travel, questionnaire, Hematopoietic Stem Cell Transplant (HSCT) recipients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Apr 2010 (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 study also aims to raise awareness among both patients and health-care providers about the importance of pre-travel health consultation and preventive interventions prior to international travel.
Through appropriate health counseling, cancer patients will have less risk of having travel -related health complications and thus have a better quality of life and overall improved sense of wellbeing.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaires | – | Behavioral: questionnairesThere will be four versions of the questionnaire, each slightly modified to be more specific toward the treatment paradigms in the respective target patient population (Breast Cancer/ Lymphoma/Autologous Bone Marrow Transplant/ Allogeneic Bone Marrow Transplant). All questionnaire versions will consist of seven sections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The goal accrual is 50 patients from each of the following oncology services: Breast, Lymphoma, Autologous Stem Cell Transplant, and Allogeneic Stem Cell Transplant.
Key inclusion criteria (9 listed)
- Hematopoietic Stem Cell Transplant (HSCT) recipients
- Age >18 years
- Status post bone marrow transplant within last five years Breast Cancer patients: Criteria 1 and Criteria 2 and/or 3
- Female age >18 years and current or past history of breast cancer
- Received systemic chemotherapy in the last five years
Key exclusion criteria (3 listed)
- Patients age< 18 years
- Breast cancer and lymphoma patients in clinical remission in the past 5 years
- Patients 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 |
|---|---|---|
| questionnairesThe intervention is a self-administered anonymous questionnaire that is voluntarily completed by the patient. Questions in Section One will cover general information about the patient including gender, age, race, country of birth, current zip code of residence, and level of education. Questions in Section Two will cover information regarding the cancer (breast/lymphoma) or transplant (allogeneic/ autologous). Questions in Section Three will cover travel history including the frequency of travel outside the United States and Canada in the last 5 years. Questions in Sections Four through Seven will obtain information about their last trip outside the United States and Canada. | Behavioural | questionnaires |
Primary outcome
To determine the frequency of international travel of the targeted patients in the last 5 years.
Time frame: once at the time of the clinic visit
4 secondary outcomes
To determine if any of the international travel was during a high-risk specific period when the immune status of the target population was compromised.
Time frame: once at the time of the clinic visit
To profile the target population who traveled internationally with respect to their demographic and cancer/transplant-related characteristics.
Time frame: once at the time of the clinic visit
To obtain detailed information about their last international trip including
Time frame: once at the time of the clinic visit
To assess the adequacy of the questionnaire instructions
Time frame: once at the time of the clinic visit
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 1 Jun 2012.
- 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 Breast Cancer and Lymphoma, 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 9 inclusion and 3 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 1 Jun 2012. 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?
To determine the frequency of international travel of the targeted patients in the last 5 years. (time frame: once at the time of the clinic visit). 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 1 Jun 2012.