- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01111201
International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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once at the time of the clinic visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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once at the time of the clinic visit
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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
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once at the time of the clinic visit
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To obtain detailed information about their last international trip including
Time Frame: once at the time of the clinic visit
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once at the time of the clinic visit
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To assess the adequacy of the questionnaire instructions
Time Frame: once at the time of the clinic visit
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once at the time of the clinic visit
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Collaborators and Investigators
Investigators
- Principal Investigator: Monika Shah, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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