NeuroblastomaNCMMNCT01525251
Nurse Case Manager Model on Neuroblastoma Caregiver's Uncertainty
An observational study of Neuroblastoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Caregiver of Neuroblastoma Childern
Who may be able to join
- Care giver of Neuroblastoma Children
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Ya-Ling Lee, RN,DNSc, +886-02-23123456 ext. 88422, yallee@ntu.edu.tw
About this study
Official title: The Effect of Nurse Case Manager Model on Caregiver's Adaptation of Disease Uncertainty About Their Child With Neuroblastoma
Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. According to the report from the Childhood Cancer Foundation ROC, several children with neuroblastoma did not complete their treatment and or not received the protocol. In addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of.
Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna.
Read more
Methods: A longitudinal and prospective design will be used to perform this study. Questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. The qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .There are five points of time to collect data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible subjects agree to participate in the study.
Subjects: The study will use a convenience sample. Once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study.
Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the self-reported socio-demographic questionnaire will be used to collect data. Process recording will be typed once finishing interview for further analysis.
Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The data will be analyzed using descriptive statistics and inferred statistics. Content analysis and theme formation will be categorized to assist the interpretation of quantitative results.
Implication: The findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors.
- Conditions
- Neuroblastoma
- Keywords
- primary caregiver, neuroblastoma, support group, posttraumatic stress, uncertainty
- Medical subject headings
- Neuroblastoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Taiwan University
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Ya-Ling Lee, RN,DNSc, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525251
- Sponsor's protocol ID
- 200907067R
- Acronym
- NCMM
- Status last verified
- Jan 2012
- First submitted
- 30 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Case Manager Model on Caregiver's Adaptation of Disease Uncertainty About Their Child With Neuroblastoma
- ClinicalTrials.gov ID
- NCT01525251
- Acronym / sponsor ID
- NCMM / 200907067R
- Conditions
- Neuroblastoma
- Keywords
- primary caregiver, neuroblastoma, support group, posttraumatic stress, uncertainty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Taiwan University
- Study start
- Aug 2009
- First posted
- 2 Feb 2012 (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.
Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. According to the report from the Childhood Cancer Foundation ROC, several children with neuroblastoma did not complete their treatment and or not received the protocol. In addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of.
Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna.
Methods: A longitudinal and prospective design will be used to perform this study. Questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. The qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .There are five points of time to collect data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible subjects agree to participate in the study.
Subjects: The study will use a convenience sample. Once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study.
Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the self-reported socio-demographic questionnaire will be used to collect data. Process recording will be typed once finishing interview for further analysis.
Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The data will be analyzed using descriptive statistics and inferred statistics. Content analysis and theme formation will be categorized to assist the interpretation of quantitative results.
Implication: The findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caregiver of Neuroblastoma Childern
Key inclusion criteria (1 listed)
- Care giver of Neuroblastoma Children
Key exclusion criteria (1 listed)
- NA
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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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.
Ya-Ling Lee, RN,DNSc principal investigator
National Taiwan University
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 Neuroblastoma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2012. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ling Lee, RN,DNSc (+886-2-23123456 ext. 88422, yallee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2 Feb 2012.