Stress and Coping in Caregivers of Younger Patients With Cancer

NCT ID: NCT02725385

Last Updated: 2018-07-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Anxiety Depression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

Correlative studies

Physiologic Testing

Intervention Type OTHER

Undergo Trier Social Stress Test

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Physiologic Testing

Undergo Trier Social Stress Test

Intervention Type OTHER

Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Other Intervention Names

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Physiologic Test Study of Physiologic Variables

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

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

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00025224

Identifier Type: -

Identifier Source: org_study_id

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