eHealth Psychosocial Intervention for Parents of Children with Pediatric Cancer

Recruiting at 2 trial locations

Overseen By Kimberly Canter, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Child life expectancy under six months

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program designed to help parents and caregivers of children with cancer manage stress and improve coping skills. The aim is to reduce distress and anxiety while boosting confidence in handling the emotional challenges of having a child with cancer. Participants are divided into two groups: one uses the eSCCIP program (Electronic Surviving Cancer Competently Intervention Program), which includes online modules and telehealth sessions, and the other accesses educational resources about coping with pediatric cancer. This trial suits parents or caregivers of children with cancer who can read English or Spanish and have internet access. As an unphased trial, it offers a unique opportunity to access supportive resources tailored for emotional resilience.

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 prior data suggests that this eHealth intervention is safe for parents of children with pediatric cancer?

Research has shown that the eSCCIP program is easy to use and helpful for caregivers. Studies suggest it can reduce stress and anxiety for parents and caregivers of children with cancer. Users found it user-friendly and appreciated it. No reports of negative side effects have emerged from using this online program, indicating that eSCCIP is safe and effective for providing emotional support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about eSCCIP and eSCCIP-SP because these treatments offer a fresh approach to supporting parents of children with pediatric cancer. Unlike traditional counseling or support groups, which often require in-person visits, eSCCIP is an entirely online program that includes interactive modules and telehealth sessions, making it more accessible for busy families. The program blends cognitive behavioral therapy with family systems therapy, targeting both individual and family coping skills, which is not typically emphasized in standard options. Additionally, eSCCIP-SP provides a culturally adapted Spanish-language version, expanding access to Spanish-speaking families and addressing a significant gap in current psychosocial support offerings.

What evidence suggests that this trial's eHealth interventions could be effective for parents of children with pediatric cancer?

Research has shown that the eSCCIP/eSCCIP-SP program, one of the interventions in this trial, effectively helps parents and caregivers of children with cancer. This program uses two proven methods: cognitive behavioral therapy and family systems therapy, both of which reduce stress and improve coping skills. Studies have found that eSCCIP lowers immediate distress and symptoms of post-traumatic stress in parents. It also boosts parents' confidence in their coping abilities and promotes positive thinking. The program is available online, making it easily accessible for families. The Spanish version, eSCCIP-SP, ensures that Spanish-speaking families can also benefit. Meanwhile, another arm of this trial provides access to Coping Space, a patient education control condition offering information about psychosocial functioning, coping, and PTSS related to pediatric cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Coping Space
• eSCCIP/eSCCIP-SP

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

A qualitative study involving focus groups and interviews with parents of children with cancer identified key strategies for improving recruitment, retention, and engagement in psychosocial interventions, emphasizing flexibility and ease of access.

The findings will inform the design of future trials for the Electronic Surviving Cancer Competently Intervention Program (eSCCIP) and highlight the importance of involving parent stakeholders in the research process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for Successful Recruitment and Retention of Parents in Pediatric Psychosocial eHealth Interventions: A Qualitative Study in Pediatric Oncology. Canter, KS., Vega, G., Ramirez, AP., et al.[2021]

Psychosocial interventions, particularly cognitive behavioral therapy and problem-solving skills training, have been shown to significantly reduce distress and improve coping strategies among parents of children with cancer, based on a review of 17 studies from 2009 to 2017.

These interventions not only support the mental health of parents but also positively impact their children's long-term adjustment to cancer, highlighting the importance of implementing these programs on a larger scale.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of psychosocial interventions targeting families of children with cancer. Koumarianou, A., Symeonidi, AE., Kattamis, A., et al.[2021]

The eSCCIP/eSCCIP-SP digital health intervention aims to provide psychosocial support to parents and caregivers of children with cancer, combining self-guided web content with telehealth sessions, and is being tested in a randomized controlled trial with 350 participants.

The primary goal of the trial is to assess the intervention's effectiveness in reducing acute distress and improving coping skills, which could lead to a scalable and impactful treatment option for families affected by childhood cancer.

NCBI (Pubmed)

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. Canter, KS., Ritterband, L., Freyer, DR., et al.[2023]

The Surviving Cancer Competently Intervention Program (SCCIP) is a one-day family group intervention designed for adolescent survivors of childhood cancer and their families, combining cognitive-behavioral and family therapy approaches.

A pilot study involving 19 families showed that SCCIP was helpful in reducing symptoms of posttraumatic stress and anxiety for all family members, indicating its potential effectiveness in addressing psychological distress after childhood cancer treatment.

NCBI (Pubmed)

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. Kazak, AE., Simms, S., Barakat, L., et al.[2022]

The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) was found to be highly acceptable, feasible, and accessible for parents of children with cancer, with 19 participants completing the intervention.

Participants experienced significant reductions in acute distress (large effect size of 0.79) and moderate decreases in PTSD symptoms, negative mood, and anxiety, suggesting eSCCIP may effectively support the psychosocial well-being of caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based trial of a psychosocial eHealth intervention for parents of children with cancer. Canter, KS., McIntyre, R., Babb, R., et al.[2022]

The eSCCIP intervention for caregivers of children with cancer demonstrated high acceptability and feasibility, with 54% enrollment and 70% retention rates, surpassing the set targets.

Caregivers reported significant reductions in symptoms of post-traumatic stress and anxiety after participating in the program, indicating its potential effectiveness in improving their psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of eSCCIP: Results From a Pilot Study of the Electronic Surviving Cancer Competently Intervention Program. Canter, KS., Vega, G., Perez Ramirez, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10276316/

The Electronic Surviving Cancer Competently Intervention ... Socioeconomic status has been found to mediate survival outcomes in pediatric cancer, with worse outcomes for Latinx and racially diverse children [13-15].

2. esccip.org esccip.org/pages/study

Study The study team has supported families of children with cancer for the past several decades. Their research started with the Surviving Cancer Competently ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10852099/

eSCCIP: A Psychosocial eHealth Intervention for Parents of ... This article describes a four-phase, mixed-methods, user-centered approach to the design and evaluation of a novel psychosocial intervention for parents of ...

4. events.cancer.gov events.cancer.gov/sites/default/files/2023-10/DCCPS%20NGW/Canter_Electronic_508.pdf

The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) - a Psychosocial Digital Health Intervention ... outcomes and improve individual and family functioning following a pediatric cancer diagnosis.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05294302

Testing eSCCIP: An eHealth Psychosocial Intervention for ... This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36303445/

Acceptability and Feasibility of eSCCIP: Results From a Pilot ... eSCCIP is an acceptable and feasible intervention for caregivers. Results are promising regarding reductions in symptoms of post-traumatic stress and anxiety.

7. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=102875

Surviving Cancer Competently Intervention Program (SCCIP) Purpose: Designed to help individuals and their caregivers enhance their skills for coping with cancer (2004). Age: 0-10 Years (Children); 11-18 ...