Clinical trial NCT02022449: Stress Management Intervention for Mothers of Children With Cancer
Official title: Stress Management Intervention for At-Risk Mothers of Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Depression
Keywords: Maternal depression
Maternal psychosocial stress and distress
Maternal health outcomes
Social support
Pediatric cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-12-27
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: baseline, 2 weeks post intervention, 6 months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Linda J. Ewing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lindsay EK, Inagaki TK, Walsh CP, Messay B, Ewing LJ, Marsland AL. Stress-Related Inflammation and Social Withdrawal in Mothers of a Child With Cancer: A 1-Year Follow-Up Study. Psychosom Med. 2022 Feb-Mar 01;84(2):141-150. doi: 10.1097/PSY.0000000000001037.
citation: Marsland AL, Walsh CP, Cleary JL, Vaisleib AD, Farrell C, Woods WC, Tersak JM, Wright A, Ewing LJ. Efficacy of a Stress Management Intervention for Mothers of Children with Cancer. J Pediatr Psychol. 2020 Jul 24:jsaa058. doi: 10.1093/jpepsy/jsaa058. Online ahead of print.