Clinical trial NCT02725385: Stress and Coping in Caregivers of Younger Patients With Cancer
Official title: Stress and Coping in Caregivers of Pediatric Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Keywords: No Evidence of Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-01
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults serving as a primary caregiver of their child

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.

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)

Primary outcomes:
measure: Level of Caregiver Distress as measured by multiple regressions analysis
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christian Waugh
role: PRINCIPAL_INVESTIGATOR
References: