NCT05333601

An eHealth Psychosocial Intervention for Caregivers of Children With Cancer

Completed NA Results posted Last updated 11 June 2024

What this trial tests

NA trial testing eSCCIP in Pediatric Cancer in 44 participants. Completed in 31 January 2022.

Timeline

1 January 2020

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	Nemours Children's Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	44
Start date	1 January 2020
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	1 location across United States

Drugs / interventions tested

• eSCCIP

Conditions studied

• Pediatric Cancer — all drugs for Pediatric Cancer →

Sponsor

Nemours Children's Clinic

Who can join

Eligibility, any sex, with Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The eSCCIP Evaluation Questionnaire Primary · Up to 6 weeks.

The eSCCIP Evaluation Questionnaire is a questionnaire designed to evaluate intervention acceptability, feasibility, and usability. Data is descriptive and examined at the item-level. Each item is scored on a 0-4 Likert scale (Not at all true - Very true). Mean score with standard deviation are reported at the item-level.

The eSCCIP website was easy to use

Group	Value	95% CI
eSCCIP	3.53	± 0.78

The eSCCIP website was convenient to use

Group	Value	95% CI
eSCCIP	3.6	± 0.68

eSCCIP was interesting.

Group	Value	95% CI
eSCCIP	3.76	± 0.44

I like how eSCCIP looked

Group	Value	95% CI
eSCCIP	3.6	± 0.68

I was worried about my privacy when using the eSCCIP website.

Group	Value	95% CI
eSCCIP	0.33	± 0.92

It was easy to log-in to the eSCCIP website.

Group	Value	95% CI
eSCCIP	3.73	± 0.58

The internet was a good method for delivering eSCCIP.

Group	Value	95% CI
eSCCIP	3.73	± 0.52

eSCCIP contained a good mix of videos and "hands on" material.

Group	Value	95% CI
eSCCIP	3.63	± 0.72

Distress Thermometer Secondary · Up to 9 weeks

Single-item indicator of psychosocial distress that is widely used in the oncology. Scores range from 1-10, with higher scores indicating more distress.

Group	Value	95% CI
eSCCIP	4.03	± 2.54

Generalized Anxiety Disorder - 7 (GAD-7) Secondary · Up to 9 weeks

Questionnaire used to assess state anxiety. Total scores range from 0-21, with higher scores indicating increased anxiety symptom severity.

Group	Value	95% CI
eSCCIP	3.81	± 3.89

SCORE-15 Secondary · Up to 9 weeks

Questionnaire used to assess various domains of family functioning. The SCORE-15 generates a cumulative score and three subscales: Strengths and Adaptability (range = 5-25), Overwhelmed by Difficulties (range = 0-20), and Disrupted Communication (range = 0-20). The cumulative sum score ranges from 5-65. Higher average scores on the 0-4 and 1-5 scales indicate "worse" family functioning on subscales and the cumulative score.

Total score

Group	Value	95% CI
eSCCIP	14.74	± 5.26

Disrupted Communication Subscale

Group	Value	95% CI
eSCCIP	3.03	± 2.11

Overwhelmed by Difficulties Subscale

Group	Value	95% CI
eSCCIP	2.26	± 2.13

Strengths and Adaptability Subscale

Group	Value	95% CI
eSCCIP	9.45	± 3.75

PTSD Checklist for DSM-5 (PCL-5) Secondary · Up to 9 weeks.

Questionnaire used to assess symptoms of Posttraumatic Stress Disorder (PTSD). Items on the PCL-5 are summed, resulting in cumulative scores ranging from 0-80. Additionally, the PCL-5 provides four index scores that parallel the symptom clusters for a DSM-5 PTSD diagnosis. Initial research suggests an overall cutoff score of 31-33 is clinically significant. Higher scores are indicative of "worse" functioning." The score range for Subscale B (5 items) is 0-20. The score range for Subscale C (2 items) is 0-8. The score range for Subscale D (7 items) is 0-28. The score range for Subscale E (6 it

PCL-5 sum score

Group	Value	95% CI
eSCCIP	11.23	± 7.76

PCL-5 subscale B

Group	Value	95% CI
eSCCIP	3.07	± 3.07

PCL-5 subscale C

Group	Value	95% CI
eSCCIP	1.55	± 1.67

PCL-5 subscale D

Group	Value	95% CI
eSCCIP	3.16	± 2.87

PCL-5 subscale E

Group	Value	95% CI
eSCCIP	3.45	± 2.50

The COVID-19 Exposure and Family Impact Scales (CEFIS) Secondary · Up to 9 weeks.

Added to study battery after development in response to COVID-19 pandemic. Exploratory analysis. The CEFIS has two parts. Part 1 (Exposure) includes the Exposure scale which consists of 25 Yes/No items with a total score of 0 to 25. Higher scores denote more (negative) exposure. Part 2 (Impact) includes the Impact and Distress scales. The Impact scale consists of 10 items which use a 4-point Likert scale (values from 1 - 4) rating impact on participant's and family's life. The mean of the 10 items is the total Impact Scale Score. Higher scores denote a more negative impact. The Distress scale

CEFIS Exposure

Group	Value	95% CI
eSCCIP	7.81	± 2.80

CEFIS Impact

Group	Value	95% CI
eSCCIP	2.60	± 0.62

CEFIS Distress

Group	Value	95% CI
eSCCIP	4.71	± 2.27

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dyadic digital health interventions: Their rationale and implementation.
   Shaffer KM, Mayberry LS, Salivar EG, Doss BD, et al · · 2022 · cited 3× · PMID 36397858 · DOI 10.1016/j.procs.2022.09.097
2. 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, Munoz Osorio A, et al · · 2023 · cited 3× · PMID 36303445 · DOI 10.1093/jpepsy/jsac082