Stress Management Intervention for Mothers of Children With Cancer (CTC)

May 29, 2015 updated by: University of Pittsburgh

Stress Management Intervention for At-Risk Mothers of Children With Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
participants only complete assessments
Experimental: Stress management
Cognitive Behavioral Stress management Coping enhancement strategies Progressive muscle relaxation Guided imagery relaxation skills Deep breathing relaxation skills Social support
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: baseline, 2 weeks post intervention, 6 months post intervention
maternal depression
baseline, 2 weeks post intervention, 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Linda J. Ewing, Ph.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 27, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO10040081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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