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Factors Related to Truth Telling in Primary Caregivers

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ClinicalTrials.gov Identifier: NCT02214446
Recruitment Status : Unknown
Verified August 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease
Primary Caregivers of Children Newly Diagnosed 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.

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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort
primary caregivers of children newly diagnosed with cancer
Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Caregivers of Children Newly Diagnosed with Cancer
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214446


Contacts
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Contact: Chen-Ni Li +886-936-806-856 jatty7320@hotmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: SHIANN-TARNG JOU, PhD    +886-2-23123456 ext 71716    stjou4@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: SHIANN-TARNG JOU, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02214446    
Other Study ID Numbers: 201311041RINC
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by National Taiwan University Hospital:
truth telling
hope
quality of life
care burden
children with cancer