Stress Management Intervention for Mothers of Children With Cancer

NCT02022449 | Completed DMC

• 1 other identifier: PRO10040081
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Depression

Keywords

Maternal depression; Maternal psychosocial stress and distress; Maternal health outcomes; Social support; Pediatric cancer

Outcome Measures

Primary Outcomes (1)

• 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

  maternal depression

  baseline, 2 weeks post intervention, 6 months post intervention

Study Arms (2)

Control

NO INTERVENTION

participants only complete assessments

Stress management

EXPERIMENTAL

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

Behavioral: Stress management

Interventions

Stress management BEHAVIORAL

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

Stress management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (3)

• 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.

  PMID: 23341547 BACKGROUND

• 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.

  PMID: 34935760 DERIVED

• 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.

  PMID: 32705121 DERIVED

MeSH Terms

Conditions

Depression; Neoplasms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Linda J. Ewing, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 27, 2013
• Study Start: September 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (1)