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Clinical Trials/NCT02725385
NCT02725385
Completed
Not Applicable

Stress and Coping in Caregivers of Pediatric Cancer Patients

Wake Forest University Health Sciences2 sites in 1 country163 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Wake Forest University Health Sciences
Enrollment
163
Locations
2
Primary Endpoint
Level of Caregiver Distress as measured by multiple regressions analysis
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This research trial studies stress and coping in caregivers of younger patients with cancer. Learning how caregivers of children with cancer experience and cope with chronic stress may help to develop effective programs for reducing caregiver stress.

Detailed Description

PRIMARY OBJECTIVES: 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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ability to read and speak English
  • 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 1 and Part 2): Must not have a family member who has already participated in the study
  • (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)

Outcomes

Primary Outcomes

Level of Caregiver Distress as measured by multiple regressions analysis

Time Frame: Up to 1 year

To examine whether coping styles alone predict psychosocial outcomes, a simple multiple regressions will be conducted with coping styles (approach and avoidant positive emotion coping strategies) as the predictors and the psychosocial outcomes as dependent variables. To examine whether treatment status moderates the impact of coping style on psychosocial outcomes, a multiple regressions with treatment status will be conducted, each coping style individually, and an interaction term of treatment status coping style in predicting each of the psychosocial outcomes.

Study Sites (2)

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