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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

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE December 5, 2016
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
Parent-Reported Resilience [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • Parent-reported Stress Survey Response [ Time Frame: 3 months ]
  • Parent-reported psychological distress Survey Response [ Time Frame: 3 months ]
  • Parent-reported social support Survey Response [ Time Frame: 3 months ]
  • Parent-reported quality of life Survey Response [ Time Frame: 3 months ]
  • Parent-reported benefit finding Survey Response [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • Parent-reported Stress Survey Response [ Time Frame: 3 months ]
  • Parent-reported psychological distress Survey Response [ Time Frame: 3 months ]
  • Parent-reported social support Survey Response [ Time Frame: 3 months ]
  • Parent-reported quality of life Survey Response [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
Official Title  ICMJE A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Pediatric Cancer
Intervention  ICMJE Behavioral: Promoting Resilience in Stress Management
Skills-based intervention designed to promote resilience resources
Other Name: PRISM
Study Arms  ICMJE
  • Experimental: Individual (1:1)
    Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
    Intervention: Behavioral: Promoting Resilience in Stress Management
  • Experimental: Group
    Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
    Intervention: Behavioral: Promoting Resilience in Stress Management
  • No Intervention: Usual Care
    Usual non-directed psychosocial supportive care
Publications * Rosenberg AR, Bradford MC, Junkins CC, Taylor M, Zhou C, Sherr N, Kross E, Curtis JR, Yi-Frazier JP. Effect of the Promoting Resilience in Stress Management Intervention for Parents of Children With Cancer (PRISM-P): A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911578. doi: 10.1001/jamanetworkopen.2019.11578.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 8, 2019)
107
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2016)
75
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998086
Other Study ID Numbers  ICMJE SC-N120
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abby Rosenberg, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seattle Children's Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP