NCT02214446

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

11 months

First QC Date

December 10, 2013

Last Update Submit

August 21, 2014

Conditions

Keywords

truth tellinghopequality of lifecare burdenchildren with cancer

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Change from baseline at family meeting at 3 months, and at 6 months

Study Arms (1)

primary caregivers of children newly diagnosed with cancer

Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Caregivers of Children Newly Diagnosed with Cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • SHIANN-TARNG JOU, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

August 12, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations