Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05294302
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2022-02-21
Brief Title:
Testing eSCCIP An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
A Randomized Controlled Trial of eSCCIP An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer PCCC in order to mitigate individual and family-level psychosocial risks This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking PCCC with study endpoints focused on decreasing negative psychosocial sequelae acute distress posttraumatic stress and anxiety and improving coping abilities coping self-efficacy cognitive coping strategies The long-term goal of this research program is to sustain and disseminate an effective scalable high-reach and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory
Detailed Description:
The psychosocial needs and risks of children with cancer and their families are well-documented in the literature including the increased risk of parental distress posttraumatic stress and anxiety There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer PCCC although many challenges exist regarding in-person intervention delivery eHealth interventions represent an exciting potential opportunity to address many of the barriers to in-person intervention delivery in this population but are not yet widely utilized in pediatric psychosocial cancer care The COVID-19 pandemic has further illuminated the need for flexible acceptable and accessible eHealth psychosocial interventions
The Electronic Surviving Cancer Competently Intervention Program eSCCIP is an innovative eHealth intervention for PCCC delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist eSCCIP aims to decrease symptoms of acute distress anxiety and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible easily accessible eHealth tool The intervention is delivered to one or two PCCC per family but content is designed to apply to the whole family system eSCCIP is grounded in principles of cognitive-behavioral and family systems therapy and is adapted from two efficacious in-person interventions for caregivers of children with cancer the Surviving Cancer Competently Intervention Program SCCIP and the Surviving Cancer Competently Intervention Program - Newly Diagnosed SCCIP-ND eSSCIP has been rigorously developed through a stakeholder-engaged development process involving close collaboration with PCCC content experts in pediatric oncology and eHealth and web design and development experts A Spanish language adaptation of eSCCIP El Programa Electronico de Intervencion para Superar Cancer Competentemente eSCCIP-SP has recently been developed following a rigorous process and is now ready for testing as well The self-guided online modules of eSCCIPeSCCIP-SP feature a mix of didactic video content novel multifamily video discussion groups featuring parents of children with cancer and hands-on interactive activities P
The objective of the proposed study is to test eSCCIPeSCCIP-SP in a rigorous multisite RCT compared to an education control condition The primary study endpoint is a reduction in acute distress from baseline to post-intervention with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety and improvements in coping self-efficacy and cognitive coping Data will be collected at three timepoints baseline post-intervention and three-month follow-up An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIPeSCCIP-SP laying the groundwork for future trials focused on dissemination and implementation stepped-care models and intervention refinement
The Electronic Surviving Cancer Competently Intervention Program eSCCIP is an innovative eHealth intervention for PCCC delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist eSCCIP aims to decrease symptoms of acute distress anxiety and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible easily accessible eHealth tool The intervention is delivered to one or two PCCC per family but content is designed to apply to the whole family system eSCCIP is grounded in principles of cognitive-behavioral and family systems therapy and is adapted from two efficacious in-person interventions for caregivers of children with cancer the Surviving Cancer Competently Intervention Program SCCIP and the Surviving Cancer Competently Intervention Program - Newly Diagnosed SCCIP-ND eSSCIP has been rigorously developed through a stakeholder-engaged development process involving close collaboration with PCCC content experts in pediatric oncology and eHealth and web design and development experts A Spanish language adaptation of eSCCIP El Programa Electronico de Intervencion para Superar Cancer Competentemente eSCCIP-SP has recently been developed following a rigorous process and is now ready for testing as well The self-guided online modules of eSCCIPeSCCIP-SP feature a mix of didactic video content novel multifamily video discussion groups featuring parents of children with cancer and hands-on interactive activities P
The objective of the proposed study is to test eSCCIPeSCCIP-SP in a rigorous multisite RCT compared to an education control condition The primary study endpoint is a reduction in acute distress from baseline to post-intervention with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety and improvements in coping self-efficacy and cognitive coping Data will be collected at three timepoints baseline post-intervention and three-month follow-up An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIPeSCCIP-SP laying the groundwork for future trials focused on dissemination and implementation stepped-care models and intervention refinement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None