N/A
N=44
An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
Pediatric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05333601 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: The eSCCIP Evaluation Questionnaire — 3.53; 3.6; 3.76; 3.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- eSCCIP (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The eSCCIP Evaluation Questionnaire |
3.53; 3.6; 3.76; 3.6; 0.33; 3.73 | — |
| SECONDARY Distress Thermometer |
4.03 | — |
| SECONDARY Generalized Anxiety Disorder - 7 (GAD-7) |
3.81 | — |
| SECONDARY SCORE-15 |
14.74; 3.03; 2.26; 9.45 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) |
11.23; 3.07; 1.55; 3.16; 3.45 | — |
| SECONDARY The COVID-19 Exposure and Family Impact Scales (CEFIS) |
7.81; 2.60; 4.71 | — |
Summary
The psychosocial needs of children with cancer and their families are well-documented in the literature, including the increased risk of parental posttraumatic stress, parental anxiety, and decreased family functioning. There is a critical need to provide evidence-based psychosocial care to parents of children with cancer, although many challenges exist with regard to 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. eSCCIP is an innovative eHealth intervention for parents of children with cancer, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of anxiety, distress, and posttraumatic stress while improving family functioning by delivering evidence-based therapeutic content through a flexible, easily accessible intervention tool. The four self-guided online modules feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. Preliminary Think Aloud testing has been completed and led to several rounds of design and functionality improvements. The objective of the proposed study is to establish feasibility and acceptability of eSCCIP in a diverse group of parents of children with cancer. A secondary, exploratory goal is to evaluate preliminary intervention effectiveness for key psychosocial outcomes. Specific Aim 1 is to identify strategies for increasing participant engagement and retention by conducting focus groups with a diverse sample of parents of children with cancer prior to pilot testing. Specific Aim 2 is to demonstrate the feasibility of eSCCIP through pilot testing with a diverse sample of parents of children with cancer. Specific Aim 3 is to evaluate preliminary effectiveness of eSCCIP through pilot testing with parents of children with cancer. The proposed study is an important first step in meeting a critical need for families of children with cancer and collecting data to power a randomized clinical trial to establish clinical efficacy.
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.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
Exclusion Criteria
- Potential participants are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment
Data sourced from ClinicalTrials.gov (NCT05333601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.