NCT05294302

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

77
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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 Progress97%
Apr 2023Jun 2026

First Submitted

Initial submission to the registry

February 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 14, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

February 21, 2022

Last Update Submit

June 13, 2025

Conditions

Keywords

eHealthpediatric cancerparentspsychosocial intervention

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 COMPARATOR

The 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.

Behavioral: eSCCIP/eSCCIP-SP

Coping Space

ACTIVE COMPARATOR

PCCC 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.

Behavioral: Coping Space

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.

eSCCIP/eSCCIP-SP
Coping SpaceBEHAVIORAL

Coping Space is a psychosocial informational website for PCCC.

Coping Space

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (3)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

NOT YET RECRUITING

Nemours Children's Health, Delaware

Wilmington, Delaware, 19803, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

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.

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Kimberly Canter, Ph.D.

CONTACT

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
Model Details: Participants will be assigned to the intervention group (eSCCIP/eSCCIP-SP) or an education control condition.
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.

Locations