Testing eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
1 other identifier
interventional
350
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedStudy Start
First participant enrolled
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 18, 2025
June 1, 2025
3.2 years
February 21, 2022
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
K-6
Questionnaire to measure acute distress.
Up to 20 weeks
Secondary Outcomes (7)
Multidimensional Scale of Perceived Social Support
Up to 20 weeks
The COVID-19 Exposure and Family Impact Scale (CEFIS)
Up to 20 weeks
Coping Self-Efficacy Scale
Up to 20 weeks
Cognitive Emotion Regulation Questionnaire
Up to 20 weeks
Distress Thermometer
Up to 20 weeks
- +2 more secondary outcomes
Study Arms (2)
eSCCIP/eSCCIP-SP
ACTIVE COMPARATORThe Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention that combines cognitive behavioral and family systems therapy to provide parents and caregivers of children with cancer (PCCC) with evidence-based coping skills and psychosocial support focused on the family unit. eSCCIP has three 30-minute, self-directed, online modules which feature a unique mix of original video content and interactive activities, supplemented by three telehealth follow-up sessions. A stakeholder-informed Spanish-language adaption of eSCCIP (eSCCIP-SP) has been developed and will be offered to Spanish-speaking PCCC. eSCCIP aims to reduce acute distress and symptoms of post-traumatic stress while increasing positive coping self-appraisal and use of cognitive coping skills.
Coping Space
ACTIVE COMPARATORPCCC randomized to the patient education control condition will be given access to a website with information about psychosocial functioning, coping, and PTSS related to pediatric cancer. This website will be hosted on the same platform as the intervention, available in English and Spanish, and will consist of information modified from CopingSpace.org. CopingSpace.org is an evidence-informed website developed by Ryan's Case for Smiles, a national organization dedicated to supporting families impacted by pediatric cancer and other chronic diseases.
Interventions
eSCCIP/eSCCIP-SP is a psychosocial eHealth intervention for PCCC. It consists of four self-guided, web-based modules (including an introductory module) and three telehealth sessions with a study interventionist.
Eligibility Criteria
You may qualify if:
- Participants must be the parent or primary caregiver of a child (ages 0 - 18 years old) diagnosed with cancer.
- Participants must be able to speak and read English or Spanish.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
You may not qualify if:
- PCCC are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nemours Children's Cliniclead
- M.D. Anderson Cancer Centercollaborator
- Children's Hospital Los Angelescollaborator
- University of Virginiacollaborator
Study Sites (3)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Nemours Children's Health, Delaware
Wilmington, Delaware, 19803, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Canter KS, Ritterband L, Freyer DR, Askins MA, Bava L, Loucas C, Arasteh K, You W, Kazak AE. The Electronic Surviving Cancer Competently Intervention Program-a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 2;12:e46339. doi: 10.2196/46339.
PMID: 37267038DERIVED
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Investigators who are not delivering the intervention and the study biostatistician will be blinded to participant assignment.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Scientist
Study Record Dates
First Submitted
February 21, 2022
First Posted
March 24, 2022
Study Start
April 14, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
No plan to share individual participant data; de-identified group data may be available to qualified researchers upon request to the principal investigator.