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PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998086
Recruitment Status : Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abby Rosenberg, Seattle Children's Hospital

Brief Summary:
Parenting a child with cancer is highly stressful. The investigators have designed a promising parent-centered intervention to bolster parent resilience and reduce stress and distress. This study will test 2 formats of the intervention (individual or group-based) and compare them to usual care.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Behavioral: Promoting Resilience in Stress Management Not Applicable

Detailed Description:

Parenting a child with cancer is highly distressing. Both during and after cancer therapy, parents may suffer from poor mental health, risky health behaviors, and financial hardship, all of which may impact patients, siblings, and the family unit. Positive psychological resources can mitigate negative outcomes. In this regard, resilience is particularly important, describing an individual's ability to maintain psychological and/or physical well-being in the face of stress.

The investigators have previously described the "Promoting Resilience in Stress Management" (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1 intervention targets four "resilience resources" over approximately 3 months: skills in stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making. Notably, every parent whose child received the PRISM requested a similar intervention for him- or herself. Hence, the investigators adapted two versions of the intervention for parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst 12 parents of children with cancer. Feedback was highly positive; however, many parents requested additional group-based social support. Second, they conducted a half-day symposium and administered small-group adaptations of the PRISM-P to 70 parents of children with serious illness. Feedback was again positive; however, the opportunity to develop individual skills was limited.

This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies and preferences for future, larger studies. Consecutive eligible parents of children with newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25 per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals, optimism, benefit-finding, psychological distress, and health behaviors, and ongoing perceptions of usefulness, feasibility, and preference.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Individual (1:1)
Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
Behavioral: Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources
Other Name: PRISM

Experimental: Group
Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
Behavioral: Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources
Other Name: PRISM

No Intervention: Usual Care
Usual non-directed psychosocial supportive care



Primary Outcome Measures :
  1. Parent-Reported Resilience [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Parent-reported Stress Survey Response [ Time Frame: 3 months ]
  2. Parent-reported psychological distress Survey Response [ Time Frame: 3 months ]
  3. Parent-reported social support Survey Response [ Time Frame: 3 months ]
  4. Parent-reported quality of life Survey Response [ Time Frame: 3 months ]
  5. Parent-reported benefit finding Survey Response [ Time Frame: 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Parents of children who:

  • Are aged 2-24 years
  • Have been diagnosed with new malignancy between 1-10 weeks prior
  • Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital
  • Has provided written informed consent (child aged 18 years and older), written assent (child aged 13-17 years), verbal assent (child aged 7-12 years).
  • Able to speak and read English language
  • Cognitively able to participate in interactive interviews

Exclusion Criteria:

  • Parent is < 18 years of age
  • Parent is cognitively or physically unable to participate in interactive interview
  • Parent is unable to speak and read English language
  • Parent or child participated on prior PRISM intervention study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998086


Locations
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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98145
Sponsors and Collaborators
Seattle Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abby Rosenberg, Associate Professor, Pediatrics, University of Washington, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02998086    
Other Study ID Numbers: SC-N120
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided