Stress and Coping in Caregivers of Younger Patients With Cancer
NCT ID: NCT02725385
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
163 participants
OBSERVATIONAL
2014-03-31
2016-05-31
Brief Summary
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Detailed Description
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I. To determine how the experience of distress and use of positive emotion coping strategies by pediatric cancer caregivers differs from caregivers of children with no chronic illnesses.
II. To determine how relationships between positive coping strategies and caregiver distress change during the different phases of a child's illness.
III. To explore how chronic caregiver stress affects physiological reactivity to and recovery from an acute laboratory stressor.
IV. To explore how different positive coping mechanisms help chronically stressed caregivers recover from acute stressors and how these efficacies change during the different phases of the child's illness.
OUTLINE:
PART I:
Participants complete a questionnaire that measures several psychological constructs including stress, anxiety, depression, coping mechanisms, uncertainty, positive and negative emotions, and life satisfaction over 15-30 minutes.
PART II:
Participants undergo a Trier Social Stress Test during a laboratory session over 1.5 hours.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Ancillary-Correlative (stress and coping)
PART I:
Participants complete a questionnaire that measures several psychological constructs including stress, anxiety, depression, coping mechanisms, uncertainty, positive and negative emotions, and life satisfaction over 15-30 minutes.
PART II:
Participants undergo a Trier Social Stress Test during a laboratory session over 1.5 hours.
Laboratory Biomarker Analysis
Correlative studies
Physiologic Testing
Undergo Trier Social Stress Test
Questionnaire Administration
Complete questionnaire
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Physiologic Testing
Undergo Trier Social Stress Test
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must serve as a primary caregiver of their child (ages 0-17) - as reported by the participant
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* (Part 2): Must not be pregnant or have a history of cardiovascular disease, hypertension, pituitary disorder, or adrenal disorder
* CONTROL PARTICIPANTS: (Part 1 and Part 2): Participants must not have a child with a chronic illness (e.g., diabetes, asthma, multiple sclerosis)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Christian Waugh
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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NCI-2014-01878
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 01413
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00025224
Identifier Type: -
Identifier Source: org_study_id
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