Thalassemia MajorNCT01129076
Perceptions of Thalassemia Major in Singapore: An Exploratory Study of Stigma
An observational study of Thalassemia Major, run by National Human Genome Research Institute (NHGRI) at 2 sites in Singapore.
Trial summary
Background: Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that carries oxygen and nutrients to cells in the body. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Thalassemia Major
- How many people
- 30 participants
- Where
- 2 sitesSingapore
- Study dates
- 23 Apr 2010to 7 Jan 2016
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals who currently have TM and receive at least 8 blood transfusions in a year
- Residents of Singapore
- Must speak English
- Parents of individuals with TM will be eligible for participation if they are age 21 years or older
- Parents must be residents of Singapore
- Parents must speak English
- For a parent to participate in the study, it will not be required that his or her child also participate in the study or vice versa.
Who cannot join
- Children under age 14 years
- Non-English speaking individuals
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital Outram Rd.
Singapore, 169608
KK Women's & Children's Hospital
Singapore
About this study
Background:
- Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that carries oxygen and nutrients to cells in the body. As a result, individuals require life-long blood transfusions and extensive medical management. Studies have shown that because of its demanding nature, TM might negatively affect an individual s quality of life, sense of self, and social integration, but little is known about affected individuals overall experiences with and perceptions of TM.
- TM is caused by a genetic change in the thalassemia gene. The disease is passed to children by parents who carry one copy of the altered thalassemia gene. The parents are called carriers of the condition and have a 25 percent chance of having a child with TM. It is possible to screen for carriers of TM and use this information for pregnancy planning and management.
- TM is common among people from South and South East Asia and is an important public health concern in Singapore. More research is needed to explore the lives of people with TM, and the societal perceptions that exist in Singapore about TM.
Read more
Objectives:
- To describe the familial, social, and professional experiences of individuals with TM.
- To investigate the social messages being given out about TM in Singapore and the sources of those messages.
- To explore the impact of these experiences, perceptions, and social messages on individuals who have TM.
- To explore how the experiences and perceptions of individuals who have TM affect their life, sense of self, social integration, and compliance with medical treatment.
Eligibility:
- Residents of Singapore who are 14 years of age or older, can speak English, and currently have TM.
- Parents of individuals with TM who are 14 years of age or older. Parents must be 21 years of age or older, be able to speak English, and have had caregiving responsibilities for their child at some point.
Design:
- All participants will have a one-time semi-structured interview, followed by a questionnaire to obtain demographic information.
- Interviews will be conducted in Singapore and are expected to last for 30 to 90 minutes.
- Individuals with TM will be asked about their own perceptions of TM; familial, social, and professional experiences involving TM; and their perceptions of others views and of social messages related to TM.
- Parents of individuals with TM will be asked about their experiences in caring for a child with TM, talking to their child about TM, telling people about their child s TM, and interacting with health care providers.
Read the detailed description
Thalassemia major (TM) is a chronic, inherited hematological disorder that can require life-long medical care. As a result of the chronic and demanding nature of the condition, studies have shown that TM might negatively affect an individual s quality of life, sense of self, social integration, and compliance with medical treatment. Yet, little is known about affected individuals overall experiences with and perceptions of TM. In this study, the concept of stigma will be used to explore and understand these experiences and perceptions in the population of individuals with TM in Singapore. This study will involve qualitative interviews with TM patients and parents of TM patients. Interviews will focus on individuals family, social and professional experiences with TM; the social messages that exist in Singapore about TM and their sources; individuals perceptions of how others view TM; individuals own perceptions of TM; and the impact of these various experiences, messages and perceptions on the individual with TM. Interviews will be conducted with approximately 20-30 individuals with TM, and 10-20 parents of individuals with TM. Interviews will be transcribed and subjected to thematic analysis to identify common themes. The results of this study will further our understanding of the psychosocial burden of TM and the potential role of stigma in this population, which may ultimately inform the care for individuals with TM. The study s setting will also provide insights into the impact of the Singaporean sociocultural context on the psychosocial elements of living with a genetic condition, which might eventually help to inform the development of appropriate psychosocial support services and genetic counseling services in the region.
- Conditions
- Thalassemia Major
- Keywords
- Thalassemia Major, Stigma, Singapore, Qualitative
- Medical subject headings
- beta-Thalassemia, Social Stigma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study start23 Apr 2010
- Study completion7 Jan 2016
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 Thalassemia MajorStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129076
- Sponsor's protocol ID
- 999910104
- Other IDs
- 10-HG-N104
- Status last verified
- 7 Jan 2016
- First submitted
- 21 May 2010
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Ismail A, Campbell MJ, Ibrahim HM, Jones GL. Health Related Quality of Life in Malaysian children with thalassaemia. Health Qual Life Outcomes. 2006 Jul 2;4:39. doi: 10.1186/1477-7525-4-39.
PubMed 16813662Hoedemaekers R, ten Have H. Geneticization: the Cyprus paradigm. J Med Philos. 1998 Jun;23(3):274-87. doi: 10.1076/jmep.23.3.274.2585.
PubMed 9736189Major B, O'Brien LT. The social psychology of stigma. Annu Rev Psychol. 2005;56:393-421. doi: 10.1146/annurev.psych.56.091103.070137.
PubMed 15709941
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions of Thalassemia Major in Singapore: An Exploratory Study of Stigma
- ClinicalTrials.gov ID
- NCT01129076
- Acronym / sponsor ID
- 999910104
- Conditions
- Thalassemia Major
- Keywords
- Thalassemia Major, Stigma, Singapore, Qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 23 Apr 2010
- Study completion
- 7 Jan 2016
- First posted
- 24 May 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:
- Thalassemia major (TM) is a chronic disorder that affects a person s ability to produce hemoglobin, resulting in anemia. Hemoglobin is a component of red blood cells that carries oxygen and nutrients to cells in the body. As a result, individuals require life-long blood transfusions and extensive medical management. Studies have shown that because of its demanding nature, TM might negatively affect an individual s quality of life, sense of self, and social integration, but little is known about affected individuals overall experiences with and perceptions of TM.
- TM is caused by a genetic change in the thalassemia gene. The disease is passed to children by parents who carry one copy of the altered thalassemia gene. The parents are called carriers of the condition and have a 25 percent chance of having a child with TM. It is possible to screen for carriers of TM and use this information for pregnancy planning and management.
- TM is common among people from South and South East Asia and is an important public health concern in Singapore. More research is needed to explore the lives of people with TM, and the societal perceptions that exist in Singapore about TM.
Objectives:
- To describe the familial, social, and professional experiences of individuals with TM.
- To investigate the social messages being given out about TM in Singapore and the sources of those messages.
- To explore the impact of these experiences, perceptions, and social messages on individuals who have TM.
- To explore how the experiences and perceptions of individuals who have TM affect their life, sense of self, social integration, and compliance with medical treatment.
Eligibility:
- Residents of Singapore who are 14 years of age or older, can speak English, and currently have TM.
- Parents of individuals with TM who are 14 years of age or older. Parents must be 21 years of age or older, be able to speak English, and have had caregiving responsibilities for their child at some point.
Design:
- All participants will have a one-time semi-structured interview, followed by a questionnaire to obtain demographic information.
- Interviews will be conducted in Singapore and are expected to last for 30 to 90 minutes.
- Individuals with TM will be asked about their own perceptions of TM; familial, social, and professional experiences involving TM; and their perceptions of others views and of social messages related to TM.
- Parents of individuals with TM will be asked about their experiences in caring for a child with TM, talking to their child about TM, telling people about their child s TM, and interacting with health care providers.
Detailed description
Thalassemia major (TM) is a chronic, inherited hematological disorder that can require life-long medical care. As a result of the chronic and demanding nature of the condition, studies have shown that TM might negatively affect an individual s quality of life, sense of self, social integration, and compliance with medical treatment. Yet, little is known about affected individuals overall experiences with and perceptions of TM. In this study, the concept of stigma will be used to explore and understand these experiences and perceptions in the population of individuals with TM in Singapore. This study will involve qualitative interviews with TM patients and parents of TM patients. Interviews will focus on individuals family, social and professional experiences with TM; the social messages that exist in Singapore about TM and their sources; individuals perceptions of how others view TM; individuals own perceptions of TM; and the impact of these various experiences, messages and perceptions on the individual with TM. Interviews will be conducted with approximately 20-30 individuals with TM, and 10-20 parents of individuals with TM. Interviews will be transcribed and subjected to thematic analysis to identify common themes. The results of this study will further our understanding of the psychosocial burden of TM and the potential role of stigma in this population, which may ultimately inform the care for individuals with TM. The study s setting will also provide insights into the impact of the Singaporean sociocultural context on the psychosocial elements of living with a genetic condition, which might eventually help to inform the development of appropriate psychosocial support services and genetic counseling services in the region.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals who currently have TM and receive at least 8 blood transfusions in a year
- Residents of Singapore
- Must speak English
- Parents of individuals with TM will be eligible for participation if they are age 21 years or older
- Parents must be residents of Singapore
Key exclusion criteria (2 listed)
- Children under age 14 years
- Non-English speaking individuals
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 17 Dec 2019.
- Background: PubMed 16813662Ismail A, Campbell MJ, Ibrahim HM, Jones GL. Health Related Quality of Life in Malaysian children with thalassaemia. Health Qual Life Outcomes. 2006 Jul 2;4:39. doi: 10.1186/1477-7525-4-39.
- Background: PubMed 9736189Hoedemaekers R, ten Have H. Geneticization: the Cyprus paradigm. J Med Philos. 1998 Jun;23(3):274-87. doi: 10.1076/jmep.23.3.274.2585.
- Background: PubMed 15709941Major B, O'Brien LT. The social psychology of stigma. Annu Rev Psychol. 2005;56:393-421. doi: 10.1146/annurev.psych.56.091103.070137.
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Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
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Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
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A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
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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.
Barbara B Biesecker principal investigator
National Human Genome Research Institute (NHGRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Major, run by National Human Genome Research Institute (NHGRI) at 2 sites in Singapore.
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 7 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 NCT01129076, 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 17 Dec 2019.