International Travel Patterns and Risk Behaviour of Breast Cancer, Lymphoma Patients and Bone Marrow Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01111201
First received: April 22, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Lymphoma
Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To obtain detailed information about their last international trip including [ Time Frame: once at the time of the clinic visit ] [ Designated as safety issue: No ]
  • To assess the adequacy of the questionnaire instructions [ Time Frame: once at the time of the clinic visit ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: questionnaires
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111201

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Monika Shah, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01111201     History of Changes
Other Study ID Numbers: 10-045
Study First Received: April 22, 2010
Last Updated: May 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Autologous Bone Marrow Transplant
Breast
Lymphoma
International travel
questionnaire
Hematopoietic Stem Cell Transplant (HSCT) recipients

Additional relevant MeSH terms:
Breast Neoplasms
Lymphoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014