NCT01111201

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

April 22, 2010

Last Update Submit

May 30, 2012

Conditions

Keywords

Autologous Bone Marrow TransplantBreastLymphomaInternational travelquestionnaireHematopoietic Stem Cell Transplant (HSCT) recipients

Outcome Measures

Primary Outcomes (1)

  • To determine the frequency of international travel of the targeted patients in the last 5 years.

    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.

    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.

    once at the time of the clinic visit

  • To obtain detailed information about their last international trip including

    once at the time of the clinic visit

  • To assess the adequacy of the questionnaire instructions

    once at the time of the clinic visit

Study Arms (1)

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

Interventions

questionnairesBEHAVIORAL

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.

questionnaires

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsLymphoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Monika Shah, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 27, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations