Clinical trial NCT05294302: Testing eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
Official title: A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: eHealth
pediatric cancer
parents
psychosocial intervention
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Children's Hospital Los Angeles
name: University of Virginia
First posted: 2022-03-24
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the intervention group (eSCCIP/eSCCIP-SP) or an education control condition.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: K-6
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Up to 20 weeks
measure: The COVID-19 Exposure and Family Impact Scale (CEFIS)
timeFrame: Up to 20 weeks
measure: Coping Self-Efficacy Scale
timeFrame: Up to 20 weeks
measure: Cognitive Emotion Regulation Questionnaire
timeFrame: Up to 20 weeks
measure: Distress Thermometer
timeFrame: Up to 20 weeks
measure: PROMIS Short Form v1.0 - Anxiety - 8a
timeFrame: Up to 20 weeks
measure: PCL-5
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Wilmington
country: United States
facility: Nemours Children's Health, Delaware
state: Delaware
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: