Pediatric CancerNCT05294302
Testing eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
A study testing eSCCIP/eSCCIP-SP and Coping Space in people with Pediatric Cancer, run by Nemours Children's Clinic at 3 sites in United States.
Trial summary
It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- eSCCIP/eSCCIP-SP and Coping Space
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 or Spanish.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
Who cannot join
- PCCC are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Martha Askins, Ph.D., maskins@mdanderson.org
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
David Freyer, DO, DFreyer@chla.usc.edu
- Recruiting
Nemours Children's Health, Delaware
Wilmington, Delaware, 19803
Kimberly Canter, 3026514501, kimberly.canter@nemours.org
About this study
Official title: A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative psychosocial sequelae (acute distress, posttraumatic stress, and anxiety) and improving coping abilities (coping self-efficacy, cognitive coping strategies). The long-term goal of this research program is to sustain and disseminate an effective, scalable, high-reach, and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory.
Read the detailed description
The psychosocial needs and risks of children with cancer and their families are well-documented in the literature, including the increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer (PCCC), although many challenges exist regarding 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. The COVID-19 pandemic has further illuminated the need for flexible, acceptable, and accessible eHealth psychosocial interventions.
The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention for PCCC, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of acute distress, anxiety, and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible, easily accessible eHealth tool. The intervention is delivered to one or two PCCC per family, but content is designed to apply to the whole family system. eSCCIP 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 through a stakeholder-engaged development process involving close collaboration with PCCC, content experts in pediatric oncology and eHealth, and web design and development experts. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has recently been developed following a rigorous process and is now ready for testing as well. The self-guided online modules of eSCCIP/eSCCIP-SP feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. P
The objective of the proposed study is to test eSCCIP/eSCCIP-SP in a rigorous, multisite RCT compared to an education control condition. The primary study endpoint is a reduction in acute distress from baseline to post-intervention, with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety ,and improvements in coping self-efficacy and cognitive coping. Data will be collected at three timepoints (baseline, post-intervention, and three-month follow-up). An additional, exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement.
- Conditions
- Pediatric Cancer
- Being tested
- eSCCIP/eSCCIP-SP, Coping Space
- Keywords
- eHealth, pediatric cancer, parents, psychosocial intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSCCIP/eSCCIP-SPBehavioural
eSCCIP/eSCCIP-SP is a psychosocial eHealth intervention for PCCC. It consists of four self-guided, web-based modules (including an introductory module) and three telehealth sessions with a study interventionist.
Coping SpaceBehavioural
Coping Space is a psychosocial informational website for PCCC.
| Study group | Role | What they receive |
|---|---|---|
| eSCCIP/eSCCIP-SP | Active comparator | 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. Receives: Behavioral: eSCCIP/eSCCIP-SP |
| Coping Space | Active comparator | 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. Receives: Behavioral: Coping Space |
What is being measured
The primary outcome is the main question the study is designed to answer.
K-6
Questionnaire to measure acute distress.
Measured: Up to 20 weeks
Secondary outcomes (7)
Multidimensional Scale of Perceived Social Support
Questionnaire to measure perceived social support from family, friends, and significant other.
Measured: Up to 20 weeks
The COVID-19 Exposure and Family Impact Scale (CEFIS)
The CEFIS assesses the extent to which a family has experienced or been "exposed" to COVID-19 related potentially traumatic events (e.g., economic changes, illness in family) and the impact of these events on the family's functioning and wellbeing.
Measured: Up to 20 weeks
Coping Self-Efficacy Scale
Questionnaire to measure perceived ability to cope effectively with challenging situations across three domains (use problem-focused coping, stop unpleasant emotions and thoughts, get support from friends and family).
Measured: Up to 20 weeks
Cognitive Emotion Regulation Questionnaire
Questionnaire to identify cognitive coping strategies used after a negative event or situation. Measures nine different cognitive coping strategies.
Measured: Up to 20 weeks
Distress Thermometer
Single-item indicator of psychosocial distress that is widely used in the oncology.
Measured: Up to 20 weeks
PROMIS Short Form v1.0 - Anxiety - 8a
Questionnaire measuring symptoms of anxiety.
Measured: Up to 20 weeks
PCL-5
Questionnaire to assess for symptoms of PTSD in civilian population.
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start14 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to the intervention group (eSCCIP/eSCCIP-SP) or an education control condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Canter, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294302
- Sponsor's protocol ID
- 1R01CA258668-01A1
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data; de-identified group data may be available to qualified researchers upon request to the principal investigator.
Publications
Canter KS, Ritterband L, Freyer DR, Askins MA, Bava L, Loucas C, Arasteh K, You W, Kazak AE. 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. JMIR Res Protoc. 2023 Jun 2;12:e46339. doi: 10.2196/46339.
PubMed 37267038
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT05294302
- Acronym / sponsor ID
- 1R01CA258668-01A1
- Conditions
- Pediatric Cancer
- Keywords
- eHealth, pediatric cancer, parents, psychosocial intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center, Children's Hospital Los Angeles, University of Virginia
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative psychosocial sequelae (acute distress, posttraumatic stress, and anxiety) and improving coping abilities (coping self-efficacy, cognitive coping strategies). The long-term goal of this research program is to sustain and disseminate an effective, scalable, high-reach, and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory.
Detailed description
The psychosocial needs and risks of children with cancer and their families are well-documented in the literature, including the increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer (PCCC), although many challenges exist regarding 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. The COVID-19 pandemic has further illuminated the need for flexible, acceptable, and accessible eHealth psychosocial interventions.
The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention for PCCC, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of acute distress, anxiety, and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible, easily accessible eHealth tool. The intervention is delivered to one or two PCCC per family, but content is designed to apply to the whole family system. eSCCIP 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 through a stakeholder-engaged development process involving close collaboration with PCCC, content experts in pediatric oncology and eHealth, and web design and development experts. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has recently been developed following a rigorous process and is now ready for testing as well. The self-guided online modules of eSCCIP/eSCCIP-SP feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. P
The objective of the proposed study is to test eSCCIP/eSCCIP-SP in a rigorous, multisite RCT compared to an education control condition. The primary study endpoint is a reduction in acute distress from baseline to post-intervention, with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety ,and improvements in coping self-efficacy and cognitive coping. Data will be collected at three timepoints (baseline, post-intervention, and three-month follow-up). An additional, exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned to the intervention group (eSCCIP/eSCCIP-SP) or an education control condition.
| Arm | Type | Receives |
|---|---|---|
| eSCCIP/eSCCIP-SP | Active comparator | Behavioral: eSCCIP/eSCCIP-SPThe 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. |
| Coping Space | Active comparator | Behavioral: Coping SpacePCCC 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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 or Spanish.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
Key exclusion criteria (1 listed)
- PCCC are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSCCIP/eSCCIP-SPeSCCIP/eSCCIP-SP is a psychosocial eHealth intervention for PCCC. It consists of four self-guided, web-based modules (including an introductory module) and three telehealth sessions with a study interventionist. | Behavioural | eSCCIP/eSCCIP-SP |
| Coping SpaceCoping Space is a psychosocial informational website for PCCC. | Behavioural | Coping Space |
Primary outcome
K-6
Time frame: Up to 20 weeks
Questionnaire to measure acute distress.
7 secondary outcomes
Multidimensional Scale of Perceived Social Support
Time frame: Up to 20 weeks
The COVID-19 Exposure and Family Impact Scale (CEFIS)
Time frame: Up to 20 weeks
Coping Self-Efficacy Scale
Time frame: Up to 20 weeks
Cognitive Emotion Regulation Questionnaire
Time frame: Up to 20 weeks
Distress Thermometer
Time frame: Up to 20 weeks
PROMIS Short Form v1.0 - Anxiety - 8a
Time frame: Up to 20 weeks
PCL-5
Time frame: Up to 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 37267038Canter KS, Ritterband L, Freyer DR, Askins MA, Bava L, Loucas C, Arasteh K, You W, Kazak AE. 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. JMIR Res Protoc. 2023 Jun 2;12:e46339. doi: 10.2196/46339.
- Individual participant dataSharing planned: No. No plan to share individual participant data; de-identified group data may be available to qualified researchers upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSCCIP/eSCCIP-SP and Coping Space in people with Pediatric Cancer, run by Nemours Children's Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Canter, Ph.D. (3026514501, kimberly.canter@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-6 (time frame: Up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05294302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.