NCT02998086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

December 13, 2016

Last Update Submit

March 15, 2021

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • Parent-Reported Resilience

    3 months

Secondary Outcomes (5)

  • Parent-reported Stress Survey Response

    3 months

  • Parent-reported psychological distress Survey Response

    3 months

  • Parent-reported social support Survey Response

    3 months

  • Parent-reported quality of life Survey Response

    3 months

  • Parent-reported benefit finding Survey Response

    3 months

Study Arms (3)

Individual (1:1)

EXPERIMENTAL

Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention

Behavioral: Promoting Resilience in Stress Management

Group

EXPERIMENTAL

Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention

Behavioral: Promoting Resilience in Stress Management

Usual Care

NO INTERVENTION

Usual non-directed psychosocial supportive care

Interventions

Promoting Resilience in Stress ManagementBEHAVIORAL

Skills-based intervention designed to promote resilience resources

Also known as: PRISM
GroupIndividual (1:1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98145, United States

Location

Related Publications (2)

  • Rosenberg AR, Zhou C, Bradford MC, Barton K, Junkins CC, Taylor M, Kross EK, Curtis JR, Dionne-Odom JN, Yi-Frazier JP. Parent Perspectives after the PRISM-P Randomized Trial: A Mixed-Methods Analysis. J Palliat Med. 2021 Sep;24(10):1505-1515. doi: 10.1089/jpm.2020.0720. Epub 2021 Mar 15.

    PMID: 33720787DERIVED

  • 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.

    PMID: 31532518DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics, University of Washington

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 20, 2016

Study Start

December 5, 2016

Primary Completion

December 30, 2018

Study Completion

December 1, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(1)