AnxietyNCT02725385
Stress and Coping in Caregivers of Younger Patients With Cancer
An observational study of Anxiety and Depression, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Laboratory Biomarker Analysis, Physiologic Testing and Questionnaire Administration
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults serving as a primary caregiver of their child
Who may be able to join
- 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
Who cannot join
- (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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Stress and Coping in Caregivers of Pediatric Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Anxiety, Depression
- Being tested
- Laboratory Biomarker Analysis, Physiologic Testing, Questionnaire Administration
- Keywords
- No Evidence of Disease
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Physiologic TestingOther
Also called Physiologic Test, Study of Physiologic Variables
Undergo Trier Social Stress Test
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Laboratory Biomarker Analysis; Other: Physiologic Testing; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Caregiver Distress as measured by multiple regressions analysis
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christian Waugh, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725385
- Sponsor's protocol ID
- IRB00025224
- Other IDs
- NCI-2014-01878, CCCWFU 01413, P30CA012197
- Status last verified
- Jun 2018
- First submitted
- 22 Feb 2016
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress and Coping in Caregivers of Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT02725385
- Acronym / sponsor ID
- IRB00025224
- Conditions
- Anxiety, Depression
- Keywords
- No Evidence of Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-Correlative (stress and coping) | – | Other: Laboratory Biomarker Analysis, Other: Physiologic Testing, Other: Questionnaire AdministrationPART 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults serving as a primary caregiver of their child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- (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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Ancillary-Correlative (stress and coping) |
| Physiologic TestingAlso: Physiologic Test, Study of Physiologic VariablesUndergo Trier Social Stress Test | Other | Ancillary-Correlative (stress and coping) |
| Questionnaire AdministrationComplete questionnaire | Other | Ancillary-Correlative (stress and coping) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Waugh principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Caregiver Distress as measured by multiple regressions analysis (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.