Stress Management Intervention for Mothers of Children With Cancer

NCT ID: NCT02022449

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

participants only complete assessments

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stress management

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

Group Type: EXPERIMENTAL

Stress management

Intervention Type: BEHAVIORAL

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

Interventions

Stress management

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda J. Ewing, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23341547 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34935760 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32705121 (View on PubMed)

Other Identifiers

PRO10040081

Identifier Type: -

Identifier Source: org_study_id