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Completed

NCT Number: NCT02725385

Stress and Coping in Caregivers of Younger Patients With Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Physiologic Testing

Other

Undergo Trier Social Stress Test

Other names: Physiologic Test, Study of Physiologic Variables

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Stress and Coping in Caregivers of Pediatric Cancer Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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