- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333601
An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
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Wilmington, Delaware, United States, 19803
- Nemours Children's Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eSCCIP
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The eSCCIP Evaluation Questionnaire
Time Frame: 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.
|
Up to 6 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress Thermometer
Time Frame: 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.
|
Up to 9 weeks
|
Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame: Up to 9 weeks
|
Questionnaire used to assess state anxiety.
Total scores range from 0-21, with higher scores indicating increased anxiety symptom severity.
|
Up to 9 weeks
|
SCORE-15
Time Frame: 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. |
Up to 9 weeks
|
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 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 items) is 0-24. Scoring guidance suggests that cumulative scores are most meaningful in terms of a provisional diagnosis of PTSD. Higher subscale scores are indicative of "worse" functioning for the specific symptom cluster assessed on that subscale. |
Up to 9 weeks.
|
The COVID-19 Exposure and Family Impact Scales (CEFIS)
Time Frame: 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 consists of 2 items with a 10-point distress scale (values from 1 - 10 for each item). The mean of these two items is the total Distress Scale Score. Higher scores denote more distress from COVID-19. The values below for Impact and Distress are the average participant subscale scores. |
Up to 9 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberly Canter, PhD, Nemours Children's Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5R03CA235002 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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