Testing eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer

Pediatric Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294302
• Other study ID #: 1R01CA258668-01A1
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Nemours Children's Clinic
• Contact: Kimberly Canter, Ph.D.
• Phone: 3026514501
• Email: kimberly.canter[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 eSCCIP/eSCCIP-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 eSCCIP/eSCCIP-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 eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• PCCC are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• eSCCIP/eSCCIP-SP
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.
• Coping Space
Coping Space is a psychosocial informational website for PCCC.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Nemours Children's Health, Delaware	Wilmington	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
Nemours Children's Clinic	Children's Hospital Los Angeles, M.D. Anderson Cancer Center, University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K-6	Questionnaire to measure acute distress.	Up to 20 weeks
Secondary	Multidimensional Scale of Perceived Social Support	Questionnaire to measure perceived social support from family, friends, and significant other.	Up to 20 weeks
Secondary	The COVID-19 Exposure and Family Impact Scale (CEFIS)	The CEFIS assesses the extent to which a family has experienced or been "exposed" to COVID-19 related potentially traumatic events (e.g., economic changes, illness in family) and the impact of these events on the family's functioning and wellbeing.	Up to 20 weeks
Secondary	Coping Self-Efficacy Scale	Questionnaire to measure perceived ability to cope effectively with challenging situations across three domains (use problem-focused coping, stop unpleasant emotions and thoughts, get support from friends and family).	Up to 20 weeks
Secondary	Cognitive Emotion Regulation Questionnaire	Questionnaire to identify cognitive coping strategies used after a negative event or situation. Measures nine different cognitive coping strategies.	Up to 20 weeks
Secondary	Distress Thermometer	Single-item indicator of psychosocial distress that is widely used in the oncology.	Up to 20 weeks
Secondary	PROMIS Short Form v1.0 - Anxiety - 8a	Questionnaire measuring symptoms of anxiety.	Up to 20 weeks
Secondary	PCL-5	Questionnaire to assess for symptoms of PTSD in civilian population.	Up to 20 weeks