Stress Management Intervention for Mothers of Children With Cancer

Not Applicable

Completed

• Conditions: Stress; Depression
• Interventions: Behavioral: Stress management

• Registration Number: NCT02022449
• Lead Sponsor: University of Pittsburgh

Brief Summary

To explore maternal biological (activation of the hypothalamic-pituitary-adrenal axis) and behavioral (smoking, sleep behavior, exercise and alcohol use) pathways of intervention-related decreases in inflammation. Hypothesis: The intervention group will show decreased levels of cortisol and improved health behaviors from pre- to post-intervention when compared with the control group. We will also explore whether intervention-related changes in these parameters predict symptoms of illness. Exploratory Aim 2. To explore psychological pathways of intervention-related decreases in distress among mothers, including the perception of social support and the use of behavioral coping strategies that are components of the intervention. Hypothesis: Increases in perceived social support and use of active behavioral coping strategies will be associated with intervention-related decreases in symptoms of depression, anxiety and psychological stress.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• biologic, adoptive, or legal guardian mothers of children (birth to 17 years) who are within 6 weeks of being newly diagnosed with any cancer, with the exception of a central nervous system (CNS) cancer or early stage lymphoma, recruited from the Division of Hematology and Oncology, Children's Hospital of Pittsburgh (CHP)
• no reported clinical history of psychotic or bipolar illness, neurological disorder (stroke, transient ischemic attacks, Parkinson's disease, multiple sclerosis) or chronic disease known to influence immune function, including cardiovascular disease, cancer [within the past 2 years], or autoimmune disease
• not taking medications that might alter responses to questionnaires or indices of immune function (including major sedatives or glucocorticoid, anti-inflammatory, anti-retroviral, or immunosuppressant medication)
• fluency in English (i.e., have commonly used English in everyday speaking and reading for at least 10 years)
• is at least 18 years of age
• not working nightshifts exclusively.

Exclusion Criteria

• mothers of children with CNS cancers due to our belief that a psychosocial intervention tailored more specifically to the unique stressors inherent in this diagnosis is warranted
• mothers of children with early stage lymphomas will be excluded because of their child's brief/mild treatment course
• mothers whose child is older than 17 years will not be eligible; the upper age limit (17 years) was established based on referral patterns at the CHP hematology/oncology department.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress management	Stress management	Cognitive Behavioral Stress management Coping enhancement strategies Progressive muscle relaxation Guided imagery relaxation skills Deep breathing relaxation skills Social support

Primary Outcome Measures

Name	Time	Method
change in Maternal depression is being assessed, the Beck Depression Inventory ( BDI), the Perceived Stress Scale (PSS) and other measures assessing maternal depression will be used	baseline, 2 weeks post intervention, 6 months post intervention	maternal depression

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States