Stress and Coping in Caregivers of Younger Patients With Cancer

NCT02725385 | Completed

• 4 other identifiers: IRB00025224NCI-2014-01878CCCWFU 01413P30CA012197
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety; Depression

Keywords

No Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 year

Study Arms (1)

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.

Other: Laboratory Biomarker Analysis; Other: Physiologic Testing; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (stress and coping)

Physiologic Testing OTHER

Undergo Trier Social Stress Test

Also known as: Physiologic Test, Study of Physiologic Variables

Ancillary-Correlative (stress and coping)

Questionnaire Administration OTHER

Complete questionnaire

Ancillary-Correlative (stress and coping)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults serving as a primary caregiver of their child

You may qualify if:

• 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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Christian Waugh

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (2)