eHealth Psychosocial Intervention for Parents of Children with Pediatric Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nemours Children's Clinic

Disqualifiers: Child life expectancy under six months

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Coping Space, eSCCIP/eSCCIP-SP, Electronic Surviving Cancer Competently Intervention Program, eSCCIP-SP for parents of children with pediatric cancer?

The eSCCIP program, which includes web-based content and telehealth sessions, has shown promise in reducing symptoms of distress and anxiety in parents of children with cancer, as well as improving family functioning. A similar program, SCCIP, demonstrated decreased posttraumatic stress and anxiety in families of adolescent cancer survivors, suggesting potential benefits for eSCCIP as well. ^{1 2 3 4 5}

Is the eHealth Psychosocial Intervention for Parents of Children with Pediatric Cancer safe?

The eHealth Psychosocial Intervention, known as eSCCIP, has been tested in various studies and is generally considered safe for parents of children with cancer. It focuses on providing support through digital content and telehealth sessions, and no safety concerns have been reported in the available research. ^{1 2 3 4 5}

How is the eSCCIP/eSCCIP-SP treatment different from other treatments for parents of children with pediatric cancer?

The eSCCIP/eSCCIP-SP treatment is unique because it is a digital health intervention specifically designed for parents of children with cancer, combining self-guided web-based content with telehealth sessions, making it more accessible and flexible compared to traditional in-person psychosocial care. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for English or Spanish speaking parents or primary caregivers of children (ages 0-18) diagnosed with cancer. They must have internet access via a computer or mobile device. Parents whose child may not survive beyond six months are excluded.

Inclusion Criteria

I am the main caregiver for a child with cancer.

I can speak and read either English or Spanish.

Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet)

Exclusion Criteria

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the eSCCIP/eSCCIP-SP program, which includes three 30-minute self-directed online modules and three telehealth follow-up sessions

Up to 20 weeks

3 telehealth follow-up sessions

Follow-up

Participants are monitored for reductions in acute distress, posttraumatic stress, and anxiety, and improvements in coping abilities

3 months

Data collection at baseline, post-intervention, and three-month follow-up

Treatment Details

Interventions

• Coping Space (Behavioral Intervention)
• eSCCIP/eSCCIP-SP (Behavioral Intervention)

Trial Overview The study tests eSCCIP/eSCCIP-SP, an online psychosocial support program aimed at reducing distress, posttraumatic stress, and anxiety among parents while enhancing coping skills during their child's cancer treatment.

Participant Groups

Group I: Coping Space Active Control 1 Intervention

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.

Group II: eSCCIP/eSCCIP-SP Active Control 1 Intervention

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Children's Hospital Los Angeles Los Angeles, CA

Nemours Children's Health, Delaware Wilmington, DE

Who Is Running the Clinical Trial?

Nemours Children's Clinic Lead Sponsor

M.D. Anderson Cancer Center Collaborator

Children's Hospital Los Angeles Collaborator

University of Virginia Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

A community-based trial of a psychosocial eHealth intervention for parents of children with cancer. [2022] The Electronic Surviving Cancer Competently Intervention Program (eSCCIP), a psychosocial eHealth intervention for parents and caregivers of children with cancer (parents), was delivered in a community-based psychosocial oncology center. Primary endpoints were intervention acceptability, feasibility, and accessibility, with a secondary exploratory focus on psychosocial outcomes.

2. Canada pubmed.ncbi.nlm.nih.gov

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. [2023] The psychosocial needs and risks of children with cancer and their families are well-documented including 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. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities.

3. United States pubmed.ncbi.nlm.nih.gov

Strategies for Successful Recruitment and Retention of Parents in Pediatric Psychosocial eHealth Interventions: A Qualitative Study in Pediatric Oncology. [2021] Psychosocial intervention studies with parents often have difficulty with regard to participant recruitment, retention, and engagement. Prior to conducting a pilot test of the Electronic Surviving Cancer Competently Intervention Program (eSCCIP), a psychosocial eHealth intervention for parents of children with cancer, a qualitative study was designed to preemptively generate strategies to address potential difficulties in these domains.

4. United States pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of eSCCIP: Results From a Pilot Study of the Electronic Surviving Cancer Competently Intervention Program. [2023] Providing high-quality psychosocial care to parents and other primary caregivers of children with cancer (henceforth referred to as caregivers) is important, given the numerous challenges associated with a pediatric cancer diagnosis and the increased risk for negative psychosocial sequelae among caregivers. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is a psychosocial eHealth intervention for caregivers, developed using an iterative, user-centered process.

5. United States pubmed.ncbi.nlm.nih.gov

Surviving cancer competently intervention program (SCCIP): a cognitive-behavioral and family therapy intervention for adolescent survivors of childhood cancer and their families. [2022] Psychological reactions to having had childhood cancer often continue after treatment ends, for survivors and their parents. Based on our previous research, we developed an intervention program for adolescent survivors of childhood cancer, their parents, and siblings. Surviving Cancer Competently: An Intervention Program--SCCIP--is a one-day family group intervention that combines cognitive-behavioral and family therapy approaches. The goals of SCCIP are to reduce symptoms of distress and to improve family functioning and development. SCCIP is described and data from a pilot study of 19 families are presented. Program evaluation data indicated that all family members found SCCIP helpful. Standardized measures administered before the intervention and again at 6 months after SCCIP showed that symptoms of posttraumatic stress and anxiety decreased. Changes in family functioning were more difficult to discern. Overall, the results were promising with regard to the feasibility of the program and its potential for reducing symptoms of distress for all family members.

6. England pubmed.ncbi.nlm.nih.gov

A review of psychosocial interventions targeting families of children with cancer. [2021] Psychosocial interventions in families of children with cancer are considered an effective way of empowering family members to tackle the complex hurdles they face. The ability of parents to develop adaptive coping strategies during the child's treatment is not only important to their own mental and physical health, but also to their child's well-being and long-term adjustment with the disease.