StressCTCNCT02022449
Stress Management Intervention for Mothers of Children With Cancer
A study testing Stress management in people with Stress and Depression, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress, Depression
- What is being tested?
- Stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: 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.
- Conditions
- Stress, Depression
- Being tested
- Stress management
- Keywords
- Maternal depression, Maternal psychosocial stress and distress, Maternal health outcomes, Social support, Pediatric cancer
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress managementBehavioural
Cognitive behavioral stress management Cognitive and emotionally focused coping enhancement strategies Progressive muscle relaxation Social support Strategies for parenting a child with cancer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 2 weeks post intervention, 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Linda J. Ewing, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022449
- Sponsor's protocol ID
- PRO10040081
- Acronym
- CTC
- Status last verified
- May 2015
- First submitted
- 27 Nov 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23341547Lindsay 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.
PubMed 34935760Marsland 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.
PubMed 32705121
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Intervention for At-Risk Mothers of Children With Cancer
- ClinicalTrials.gov ID
- NCT02022449
- Acronym / sponsor ID
- CTC / PRO10040081
- Conditions
- Stress, Depression
- Keywords
- Maternal depression, Maternal psychosocial stress and distress, Maternal health outcomes, Social support, Pediatric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Sep 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –participants only complete assessments |
| Stress management | Experimental | Behavioral: Stress managementCognitive Behavioral Stress management Coping enhancement strategies Progressive muscle relaxation Guided imagery relaxation skills Deep breathing relaxation skills Social support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress managementCognitive behavioral stress management Cognitive and emotionally focused coping enhancement strategies Progressive muscle relaxation Social support Strategies for parenting a child with cancer | Behavioural | Stress management |
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
Time frame: baseline, 2 weeks post intervention, 6 months post intervention
maternal depression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Background: PubMed 23341547Marsland 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.
- Derived from this study: PubMed 34935760Lindsay 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.
- Derived from this study: PubMed 32705121Marsland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J. Ewing, Ph.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress management in people with Stress and Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: baseline, 2 weeks post intervention, 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022449, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.