An eHealth Psychosocial Intervention for Caregivers of Children With Cancer

NCT05333601 | Completed Results

• 1 other identifier: 5R03CA235002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• The eSCCIP Evaluation Questionnaire

  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.

  Up to 6 weeks.

Secondary Outcomes (5)

• Distress Thermometer

  Up to 9 weeks

• Generalized Anxiety Disorder - 7 (GAD-7)

  Up to 9 weeks

• SCORE-15

  Up to 9 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  Up to 9 weeks.

• The COVID-19 Exposure and Family Impact Scales (CEFIS)

  Up to 9 weeks.

Study Arms (1)

eSCCIP

EXPERIMENTAL

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. eSCCIP aims to reduce acute distress and symptoms of post-traumatic stress while increasing positive coping self-appraisal and use of cognitive coping skills.

Behavioral: eSCCIP

Interventions

eSCCIP BEHAVIORAL

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. eSCCIP aims to reduce acute distress and symptoms of post-traumatic stress while increasing positive coping self-appraisal and use of cognitive coping skills.

eSCCIP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- Potential participants are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Kimberly Canter
• Organization: Nemours Children's Health

kimberly.canter@nemours.org

3026514501

Study Officials

• Kimberly Canter, PhD

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Single group pilot study

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: January 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 11, 2024
• Results First Posted: October 19, 2022

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)