Primary Caregivers of Children Newly Diagnosed With CancerNCT02214446
Factors Related to Truth Telling in Primary Caregivers
An observational study of Primary Caregivers of Children Newly Diagnosed With Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Caregivers of Children Newly Diagnosed With Cancer
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2014
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Caregivers of Children Newly Diagnosed with Cancer
Who may be able to join
- Primary caregivers of children newly diagnosed with cancer must be aged 20 years or older.
- Who can communicate in Chinese and Taiwanese.
- Consciousness clear.
- Normal cognitive function.
- After the explanation, agreed to participate in the study and signed a consent form.
- The age of children newly diagnosed with cancer is between 0 and 18 years old, who are newly diagnosed with cancer, before determined treatment plan.
- The physician of children newly diagnosed with cancer, who were willing to participate this study and signed a consent form.
Who cannot join
- Primary caregivers of children newly diagnosed with cancer, who have been diagnosed mental illness.
- The children were cancer recurrence.
- The physician of children newly diagnosed with cancer, who were not willing to participate this study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
SHIANN-TARNG JOU, PhD, +886-2-23123456 ext. 71716, stjou4@gmail.com
About this study
Official title: Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer
The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.
Read the detailed description
Background: Over the last 50 years, telling truth in adult with cancer was direct. However, studies of truth telling in newly diagnosed children with cancer were seldom. Explore the factors and experiences related to truth telling in primary caregivers of children newly diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of truth telling in primary caregivers of newly diagnosed children with cancer.
Purpose: The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.
Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze. By using the frequency, percentage, mean, and standard deviation to describe demographic information and current status of truth telling. By using the mean, standard deviation, maximum and minimum to analyze hope, care burden, and quality of life. Demographic information, medical information data, truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Pearson correlation coefficients; the change and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Generalized estimating equation.
Limitation: Studying in one medical center in Taipei, it could not estimate the country's primary caregivers of newly diagnosed children with cancer in conclusions. Because of the limitation of the manpower, time and case numbers, study tracked only six month, could not be assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling and quality of life in primary caregivers of newly diagnosed children with cancer.
- Keywords
- truth telling, hope, quality of life, care burden, children with cancer
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| primary caregivers of children newly diagnosed with cancer | Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary caregivers' Herth Hope Index
The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months.
We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment.
There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86.
The higher the score is, the greater the hope is.
Measured: Change from baseline at family meeting at 3 months, and at 6 months
primary caregivers' quality of life index
The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months.
We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment.
There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.
Measured: Change from baseline at family meeting at 3 months, and at 6 months
primary caregivers' truth telling
The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months.
Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.
Measured: Change from baseline at family meeting at 3 months, and at 6 months
primary caregivers' care burden
The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months.
We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment.
There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91.
The higher the score is, the heavier the care burden is.
Measured: Change from baseline at family meeting at 3 months, and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Caregivers of Children Newly Diagnosed With CancerStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SHIANN-TARNG JOU, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214446
- Sponsor's protocol ID
- 201311041RINC
- Status last verified
- Aug 2014
- First submitted
- 10 Dec 2013
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT02214446
- Acronym / sponsor ID
- 201311041RINC
- Keywords
- truth telling, hope, quality of life, care burden, children with cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Aug 2014 (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.
The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.
Detailed description
Background: Over the last 50 years, telling truth in adult with cancer was direct. However, studies of truth telling in newly diagnosed children with cancer were seldom. Explore the factors and experiences related to truth telling in primary caregivers of children newly diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of truth telling in primary caregivers of newly diagnosed children with cancer.
Purpose: The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.
Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze. By using the frequency, percentage, mean, and standard deviation to describe demographic information and current status of truth telling. By using the mean, standard deviation, maximum and minimum to analyze hope, care burden, and quality of life. Demographic information, medical information data, truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Pearson correlation coefficients; the change and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Generalized estimating equation.
Limitation: Studying in one medical center in Taipei, it could not estimate the country's primary caregivers of newly diagnosed children with cancer in conclusions. Because of the limitation of the manpower, time and case numbers, study tracked only six month, could not be assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling and quality of life in primary caregivers of newly diagnosed children with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| primary caregivers of children newly diagnosed with cancer | – | –Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Caregivers of Children Newly Diagnosed with Cancer
Key inclusion criteria (7 listed)
- Primary caregivers of children newly diagnosed with cancer must be aged 20 years or older.
- Who can communicate in Chinese and Taiwanese.
- Consciousness clear.
- Normal cognitive function.
- After the explanation, agreed to participate in the study and signed a consent form.
Key exclusion criteria (3 listed)
- Primary caregivers of children newly diagnosed with cancer, who have been diagnosed mental illness.
- The children were cancer recurrence.
- The physician of children newly diagnosed with cancer, who were not willing to participate this study.
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
primary caregivers' Herth Hope Index
Time frame: Change from baseline at family meeting at 3 months, and at 6 months
The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months. We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment. There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86. The higher the score is, the greater the hope is.
primary caregivers' quality of life index
Time frame: Change from baseline at family meeting at 3 months, and at 6 months
The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months. We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment. There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.
primary caregivers' truth telling
Time frame: Change from baseline at family meeting at 3 months, and at 6 months
The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months. Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.
primary caregivers' care burden
Time frame: Change from baseline at family meeting at 3 months, and at 6 months
The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months. We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment. There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91. The higher the score is, the heavier the care burden is.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
Related trials for Primary Caregivers of Children Newly Diagnosed With Cancer
Not yet recruitingObservational study
Examination of the Relationship Between Quality of Life and Caregiving Burden Among Caregivers of Pediatric Oncology Patients
Childhood Cancer, Childhood Cancers
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.
SHIANN-TARNG JOU, PhD principal investigator
National Taiwan University Hospital
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 Primary Caregivers of Children Newly Diagnosed With Cancer, 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 7 inclusion and 3 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 22 Aug 2014. 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 Chen-Ni Li (+886-936-806-856, jatty7320@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary caregivers' Herth Hope Index (time frame: Change from baseline at family meeting at 3 months, and at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 22 Aug 2014.