CancerNCT01211990
An Exploratory Study of the Characteristics of and Challenges for International Families Seeking Medical Care in the United States
An observational study of Cancer and Allogeneic Peripheral Blood Stem Cell Transplant, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: State-of-the art care for children with cancer or rare diseases is not available in all countries. Owing to the proximity of Latin America and the growing numbers of Latinos already in the United States, many international patients receiving specialized medical care in U.S. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Allogeneic Peripheral Blood Stem Cell Transplant, Bone Marrow Transplantation
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2010to 13 May 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers of children aged 0-25.
- The children of the participants must be involved in clinical research or be receiving treatment for their child s medical condition. This includes but is not limited to oncological and hematological diseases, conditions requiring transplant, and rare immunodeficiency or genetic conditions.
- The family traveled to the US for the purpose of addressing their child s medical condition.
- Caregivers must be from a country outside of the United States. Care givers must be fluent in Spanish or English.
- Caregiver has been away from the country of origin for a minimum of three months.
- The child s treatment protocol PI must agree to have the research team contact potential participants in order to explore their interest in this protocol.
Who cannot join
- The caregiver participant immigrated to the US for reasons other than enrolling in a research study or addressing their child s medical condition.
- Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the caregiver s ability to engage in the interview or is likely to interfere with the study procedures or results.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- State-of-the art care for children with cancer or rare diseases is not available in all countries. Owing to the proximity of Latin America and the growing numbers of Latinos already in the United States, many international patients receiving specialized medical care in U.S. hospitals are from Spanish-speaking countries. Although there are benefits associated with obtaining specialized care in the United States, linguistic barriers and cultural differences as well as the general stresses of caring for a child with a serious illness may affect families ability to obtain adequate care for their children. Researchers are interested in exploring the experiences and needs of international Latino families receiving medical care for their child in the United States in order to help health care centers provide more appropriate resources and improve the overall quality of culturally sensitive care.
Read more
Objectives:
- To understand the experiences of international Latino families who are receiving treatment for their child or have enrolled their child in a research study in the United States.
Eligibility:
- Caregivers of a child between birth and 25 years of ages who are from Latin America (which includes Mexico, all countries in Central America and South America, and Spanish-speaking Caribbean countries) and who have traveled to the United States to enroll their child in a research protocol and/or seek treatment for their child s medical condition.
- Caregivers must have a child enrolled on a research protocol at the time of this study.
- Caregivers must have been away from their country of origin for a minimum of 3 months.
Design:
- This study requires a single interview that should take approximately 1 hour.
- Participants will complete the interview with a member of the research team who is bilingual or fluent in Spanish.
- Participants will be asked open-ended questions about why they chose to come to the United States, how they are adjusting to living and getting medical care for their child in the United States, and what hopes they have for treatment outcomes and future medical care.
- Researchers will record the interviews to be reviewed later. The recordings will be used for this study only.
Read the detailed description
Background:
The number of individuals who choose to travel out of their native country for medical treatment in the United States has been growing (Purnell \& Paulanka, 1998). State-of-the art care for children with cancer or rare diseases is not available in all countries, especially those where the ubiquity of cancer is a new phenomenon (Granda-Cameron, 1999). Due to the proximity of Latin America and the growing numbers of Latinos already in the United States, many, though not all, of the international patients being treated in U.S. hospitals are from Spanish-speaking countries (Coatsworth, Duncan, Pantin, \& Szapocznik, 2006). While there are benefits associated with obtaining care in the United States such as improved access to specialized medical services, barriers posed by linguistic and cultural differences may play a role in the provision of adequate care for these children and their families. Additional challenges associated with receiving care in another country include failure to adhere to medical regimen due to breakdowns in communication, increased stress upon the caregiver to navigate a foreign health system and adjust to a foreign culture, and being uprooted from supportive social networks and family members (Flores, Abreu, Schwartz, \& Hill, 2000). Parents of children with more severe and/or complex diseases may find themselves settling in the United States at the cost of leaving behind loved ones and careers in their country of origin. Provision of optimal care for these patients includes addressing the adjustment needs of their families; the caregiver-patient relationship has a significant influence on the child s physical and psychological outcomes (Brown et al., 2008). Exploring the experiences and needs of internationalfamilies that come to the United States seeking medical care for their child may help health care centers to provide more appropriate resources and may improve the overall quality of culturally-sensitive care provided to these families.
Objective: This is a pilot, exploratory study designed to obtain greater understanding about the unique experiences of international families, mostly Latino families, who choose to participate in clinical research or seek medical treatment in the United States. Due to the lack of research on this phenomenon, the study will utilize qualitative methods to extrapolate the main themes that characterize this experience. The end goal of the study is to identify unique risk and protective factors that link directly to feasible interventions, so that we can provide this growing population with the standard of care expected by the mission of the NIH.
Aims:
To identify factors affecting the decision by international caregivers to seek treatment in the United States, with a specific focus on how medical information is obtained and utilized in the decision-making process.
To explore the experience of international caregivers in adapting to the medical and social culture of the United States.
To explore the thoughts and concerns of international caregivers regarding termination of treatment and subsequent re-entry into their native country.
To identify the presence and kind of positive growth experiences that occur in international families seeking medical care in the United States
To develop a set of concrete risk and protective factors associated with this experience in order to link to feasible interventions.
(The term caregiver in this protocol is used to encapsulate any individual, such as a parent, close relative, foster parent, or head of household, who attends to the needs of the ill child.)
Study Population:
This is a study taking place at the National Institutes of Health (NIH). All caregivers of a child between the ages of 0-25 from a foreign country who have traveled to the United States for the purpose of enrolling in a research protocol and/or seeking treatment for their child s medical condition will be invited to participate in this study. Caregivers who immigrated to the United States for reasons other than obtaining these services for their child s condition will not be eligible to enroll in this study. Given the present demographic populations at NIH, it is expected that participants will include, but not be limited to, individuals from the Caribbean, Dominican Republic, Puerto Rico, Chile, Peru, Guatemala, and Mexico. This sampling frame ensures that the presence of black, white, and mixed race individuals will be represented, acknowledging ethnicities that are often overlooked in studies focusing specifically on the experience of a given ethnic or racial group.
Socioeconomic situation of the families is expected to vary widely; at NIH, individuals who meet the criteria for this study are from all different socioeconomic strata and have varying levels of education.
Design:
This is a qualitative study that will utilize narrative interview techniques to gather data, and content analysis techniques to analyze data. Data will be gathered according to theories of saturation of content, while collecting sufficient data to ensure credibility and face validity (Mays \& Pope, 2000). NVivo, a validated quantitative research tool will be used for data analysis.
- Keywords
- Pediatric, Children, Cancer, Bone Marrow Transplant
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study start31 Aug 2010
- Study completion13 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Maryland Pao, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211990
- Sponsor's protocol ID
- 100192
- Other IDs
- 10-M-0192
- Status last verified
- 13 May 2013
- First submitted
- 29 Sep 2010
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Abbe M, Simon C, Angiolillo A, Ruccione K, Kodish ED. A survey of language barriers from the perspective of pediatric oncologists, interpreters, and parents. Pediatr Blood Cancer. 2006 Nov;47(6):819-24. doi: 10.1002/pbc.20841.
PubMed 16615062Alegria M, Canino G, Rios R, Vera M, Calderon J, Rusch D, Ortega AN. Inequalities in use of specialty mental health services among Latinos, African Americans, and non-Latino whites. Psychiatr Serv. 2002 Dec;53(12):1547-55. doi: 10.1176/appi.ps.53.12.1547.
PubMed 12461214Barakat LP, Kazak AE, Meadows AT, Casey R, Meeske K, Stuber ML. Families surviving childhood cancer: a comparison of posttraumatic stress symptoms with families of healthy children. J Pediatr Psychol. 1997 Dec;22(6):843-59. doi: 10.1093/jpepsy/22.6.843.
PubMed 9494321
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Characteristics of and Challenges for International Families Seeking Medical Care in the United States
- ClinicalTrials.gov ID
- NCT01211990
- Acronym / sponsor ID
- 100192
- Keywords
- Pediatric, Children, Cancer, Bone Marrow Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 31 Aug 2010
- Study completion
- 13 May 2013
- First posted
- 30 Sep 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.
Background:
- State-of-the art care for children with cancer or rare diseases is not available in all countries. Owing to the proximity of Latin America and the growing numbers of Latinos already in the United States, many international patients receiving specialized medical care in U.S. hospitals are from Spanish-speaking countries. Although there are benefits associated with obtaining specialized care in the United States, linguistic barriers and cultural differences as well as the general stresses of caring for a child with a serious illness may affect families ability to obtain adequate care for their children. Researchers are interested in exploring the experiences and needs of international Latino families receiving medical care for their child in the United States in order to help health care centers provide more appropriate resources and improve the overall quality of culturally sensitive care.
Objectives:
- To understand the experiences of international Latino families who are receiving treatment for their child or have enrolled their child in a research study in the United States.
Eligibility:
- Caregivers of a child between birth and 25 years of ages who are from Latin America (which includes Mexico, all countries in Central America and South America, and Spanish-speaking Caribbean countries) and who have traveled to the United States to enroll their child in a research protocol and/or seek treatment for their child s medical condition.
- Caregivers must have a child enrolled on a research protocol at the time of this study.
- Caregivers must have been away from their country of origin for a minimum of 3 months.
Design:
- This study requires a single interview that should take approximately 1 hour.
- Participants will complete the interview with a member of the research team who is bilingual or fluent in Spanish.
- Participants will be asked open-ended questions about why they chose to come to the United States, how they are adjusting to living and getting medical care for their child in the United States, and what hopes they have for treatment outcomes and future medical care.
- Researchers will record the interviews to be reviewed later. The recordings will be used for this study only.
Detailed description
Background:
The number of individuals who choose to travel out of their native country for medical treatment in the United States has been growing (Purnell \& Paulanka, 1998). State-of-the art care for children with cancer or rare diseases is not available in all countries, especially those where the ubiquity of cancer is a new phenomenon (Granda-Cameron, 1999). Due to the proximity of Latin America and the growing numbers of Latinos already in the United States, many, though not all, of the international patients being treated in U.S. hospitals are from Spanish-speaking countries (Coatsworth, Duncan, Pantin, \& Szapocznik, 2006). While there are benefits associated with obtaining care in the United States such as improved access to specialized medical services, barriers posed by linguistic and cultural differences may play a role in the provision of adequate care for these children and their families. Additional challenges associated with receiving care in another country include failure to adhere to medical regimen due to breakdowns in communication, increased stress upon the caregiver to navigate a foreign health system and adjust to a foreign culture, and being uprooted from supportive social networks and family members (Flores, Abreu, Schwartz, \& Hill, 2000). Parents of children with more severe and/or complex diseases may find themselves settling in the United States at the cost of leaving behind loved ones and careers in their country of origin. Provision of optimal care for these patients includes addressing the adjustment needs of their families; the caregiver-patient relationship has a significant influence on the child s physical and psychological outcomes (Brown et al., 2008). Exploring the experiences and needs of internationalfamilies that come to the United States seeking medical care for their child may help health care centers to provide more appropriate resources and may improve the overall quality of culturally-sensitive care provided to these families.
Objective: This is a pilot, exploratory study designed to obtain greater understanding about the unique experiences of international families, mostly Latino families, who choose to participate in clinical research or seek medical treatment in the United States. Due to the lack of research on this phenomenon, the study will utilize qualitative methods to extrapolate the main themes that characterize this experience. The end goal of the study is to identify unique risk and protective factors that link directly to feasible interventions, so that we can provide this growing population with the standard of care expected by the mission of the NIH.
Aims:
To identify factors affecting the decision by international caregivers to seek treatment in the United States, with a specific focus on how medical information is obtained and utilized in the decision-making process.
To explore the experience of international caregivers in adapting to the medical and social culture of the United States.
To explore the thoughts and concerns of international caregivers regarding termination of treatment and subsequent re-entry into their native country.
To identify the presence and kind of positive growth experiences that occur in international families seeking medical care in the United States
To develop a set of concrete risk and protective factors associated with this experience in order to link to feasible interventions.
(The term caregiver in this protocol is used to encapsulate any individual, such as a parent, close relative, foster parent, or head of household, who attends to the needs of the ill child.)
Study Population:
This is a study taking place at the National Institutes of Health (NIH). All caregivers of a child between the ages of 0-25 from a foreign country who have traveled to the United States for the purpose of enrolling in a research protocol and/or seeking treatment for their child s medical condition will be invited to participate in this study. Caregivers who immigrated to the United States for reasons other than obtaining these services for their child s condition will not be eligible to enroll in this study. Given the present demographic populations at NIH, it is expected that participants will include, but not be limited to, individuals from the Caribbean, Dominican Republic, Puerto Rico, Chile, Peru, Guatemala, and Mexico. This sampling frame ensures that the presence of black, white, and mixed race individuals will be represented, acknowledging ethnicities that are often overlooked in studies focusing specifically on the experience of a given ethnic or racial group.
Socioeconomic situation of the families is expected to vary widely; at NIH, individuals who meet the criteria for this study are from all different socioeconomic strata and have varying levels of education.
Design:
This is a qualitative study that will utilize narrative interview techniques to gather data, and content analysis techniques to analyze data. Data will be gathered according to theories of saturation of content, while collecting sufficient data to ensure credibility and face validity (Mays \& Pope, 2000). NVivo, a validated quantitative research tool will be used for data analysis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregivers of children aged 0-25.
- The children of the participants must be involved in clinical research or be receiving treatment for their child s medical condition. This includes but is not limited to oncological and hematological diseases, conditions requiring transplant, and rare immunodeficiency or genetic conditions.
- The family traveled to the US for the purpose of addressing their child s medical condition.
- Caregivers must be from a country outside of the United States. Care givers must be fluent in Spanish or English.
- Caregiver has been away from the country of origin for a minimum of three months.
Key exclusion criteria (2 listed)
- The caregiver participant immigrated to the US for reasons other than enrolling in a research study or addressing their child s medical condition.
- Presence of psychotic symptoms or severe psychological distress, which in the judgment of the Principal or Associate Investigator or consulting psychiatrist would compromise the caregiver s ability to engage in the interview or is likely to interfere with the study procedures or results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Oct 2017.
- Background: PubMed 16615062Abbe M, Simon C, Angiolillo A, Ruccione K, Kodish ED. A survey of language barriers from the perspective of pediatric oncologists, interpreters, and parents. Pediatr Blood Cancer. 2006 Nov;47(6):819-24. doi: 10.1002/pbc.20841.
- Background: PubMed 12461214Alegria M, Canino G, Rios R, Vera M, Calderon J, Rusch D, Ortega AN. Inequalities in use of specialty mental health services among Latinos, African Americans, and non-Latino whites. Psychiatr Serv. 2002 Dec;53(12):1547-55. doi: 10.1176/appi.ps.53.12.1547.
- Background: PubMed 9494321Barakat LP, Kazak AE, Meadows AT, Casey R, Meeske K, Stuber ML. Families surviving childhood cancer: a comparison of posttraumatic stress symptoms with families of healthy children. J Pediatr Psychol. 1997 Dec;22(6):843-59. doi: 10.1093/jpepsy/22.6.843.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Maryland Pao, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 Cancer and Allogeneic Peripheral Blood Stem Cell Transplant, run by National Institute of Mental Health (NIMH) 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 6 inclusion and 2 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 6 Oct 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01211990, which also lists 3 linked publications.
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 6 Oct 2017.