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Stress and Coping in Caregivers of Younger Patients With Cancer

Stress and Coping in Caregivers of Pediatric Cancer Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02725385
Enrollment
163
Registered
2016-04-01
Start date
2014-03-31
Completion date
2016-05-31
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

No Evidence of Disease

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.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

OTHERPhysiologic Testing

Undergo Trier Social Stress Test

OTHERQuestionnaire Administration

Complete questionnaire

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Level of Caregiver Distress as measured by multiple regressions analysisUp to 1 yearTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026