PatientsVille.com LogoPatientsVille.com

Stress | Stress Management Intervention for Mothers of Children With Cancer

Stress research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Stress

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Stress managementCognitive behavioral stress management Cognitive and emotionally focused coping enhancement strategies Progressive muscle relaxation Social support Strategies for parenting a child with cancer

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Controlparticipants only complete assessments

Stress managementCognitive Behavioral Stress management Coping enhancement strategies Progressive muscle relaxation Guided imagery relaxation skills Deep breathing relaxation skills Social support

Study Status

Completed

Start Date: September 2010

Completed Date: March 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Linda J. Ewing, Ph.D.

Lead Sponsor: University of Pittsburgh

Collaborator: American Cancer Society, Inc.

More information:https://clinicaltrials.gov/show/NCT02022449

Marsland AL, Long KA, Howe C, Thompson AL, Tersak J, Ewing LJ. A pilot trial of a stress management intervention for primary caregivers of children newly diagnosed with cancer: preliminary evidence that perceived social support moderates the psychosocial benefit of intervention. J Pediatr Psychol. 2013 May;38(4):449-61. doi: 10.1093/jpepsy/jss173. Epub 2013 Jan 21.

Discuss Stress