Clinical trial NCT05333601: An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
Official title: An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pilot study
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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. For example, it can be difficult for parents to schedule additional in-person appointments during cancer treatment, and many pediatric cancer centers lack adequately trained psychosocial staff. 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 intervention is grounded in principles of cognitive-behavioral and family systems therapy and is adapted from two efficacious in-person interventions for caregivers of children with cancer, the Surviving Cancer Competently Intervention Program (SCCIP) and the Surviving Cancer Competently Intervention Program - Newly Diagnosed (SCCIP-ND). eSSCIP has been rigorously developed over two years through a stakeholder-engaged development process involving close collaboration with parents of children with cancer, content experts in pediatric oncology and eHealth, and web design and development experts. 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

Primary outcomes:
measure: The eSCCIP Evaluation Questionnaire
timeFrame: Up to 6 weeks.
Secondary outcomes:
measure: Distress Thermometer
timeFrame: Up to 9 weeks
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Up to 9 weeks
measure: SCORE-15
timeFrame: Up to 9 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Up to 9 weeks.
measure: The COVID-19 Exposure and Family Impact Scales (CEFIS)
timeFrame: Up to 9 weeks.
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Health
state: Delaware
Study officials:
affiliation: Nemours Children's Health
name: Kimberly Canter, PhD
role: PRINCIPAL_INVESTIGATOR
References: