Trial Outcomes & Findings for An eHealth Psychosocial Intervention for Caregivers of Children With Cancer (NCT NCT05333601)
NCT ID: NCT05333601
Last Updated: 2024-06-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Up to 6 weeks.
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
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.
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.
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Overall Study
STARTED
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44
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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13
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
Baseline characteristics by cohort
| Measure |
eSCCIP
n=44 Participants
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: 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.
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Age, Continuous
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35.86 years
STANDARD_DEVIATION 9.66 • n=5 Participants
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Sex: Female, Male
Female
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39 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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36 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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12 Participants
n=5 Participants
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Race (NIH/OMB)
White
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25 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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44 Participants
n=5 Participants
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Number of Participants that Completed Investigator Derived Baseline Questionnaire
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44 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
eSCCIP
n=30 Participants
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: 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.
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The eSCCIP Evaluation Questionnaire
The eSCCIP website was easy to use
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3.53 score on a scale
Standard Deviation 0.78
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The eSCCIP Evaluation Questionnaire
The eSCCIP website was convenient to use
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3.6 score on a scale
Standard Deviation 0.68
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The eSCCIP Evaluation Questionnaire
eSCCIP was interesting.
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3.76 score on a scale
Standard Deviation 0.44
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The eSCCIP Evaluation Questionnaire
I like how eSCCIP looked
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3.6 score on a scale
Standard Deviation 0.68
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The eSCCIP Evaluation Questionnaire
I was worried about my privacy when using the eSCCIP website.
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0.33 score on a scale
Standard Deviation 0.92
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The eSCCIP Evaluation Questionnaire
It was easy to log-in to the eSCCIP website.
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3.73 score on a scale
Standard Deviation 0.58
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The eSCCIP Evaluation Questionnaire
The internet was a good method for delivering eSCCIP.
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3.73 score on a scale
Standard Deviation 0.52
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The eSCCIP Evaluation Questionnaire
eSCCIP contained a good mix of videos and "hands on" material.
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3.63 score on a scale
Standard Deviation 0.72
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The eSCCIP Evaluation Questionnaire
It was easy to complete telehealth follow-up sessions with the telehealth interventionist.
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3.77 score on a scale
Standard Deviation 0.63
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The eSCCIP Evaluation Questionnaire
It was convenient to complete telehealth follow-up sessions with the telehealth interventionist.
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3.80 score on a scale
Standard Deviation 0.61
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The eSCCIP Evaluation Questionnaire
The telehealth follow-up sessions were an important part of eSCCIP.
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3.83 score on a scale
Standard Deviation 0.46
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The eSCCIP Evaluation Questionnaire
There were enough telehealth follow-up sessions in eSCCIP.
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3.62 score on a scale
Standard Deviation 0.68
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The eSCCIP Evaluation Questionnaire
eSCCIP was helpful.
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3.90 score on a scale
Standard Deviation 0.31
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The eSCCIP Evaluation Questionnaire
I learned something new from participating in eSCCIP.
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3.90 score on a scale
Standard Deviation 0.40
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The eSCCIP Evaluation Questionnaire
It was easy for me to understand the information in eSCCIP.
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3.90 score on a scale
Standard Deviation 0.31
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The eSCCIP Evaluation Questionnaire
I trusted the information that was presented in eSCCIP.
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3.93 score on a scale
Standard Deviation 0.26
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The eSCCIP Evaluation Questionnaire
The topics covered in eSCCIP were relevant to me.
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3.87 score on a scale
Standard Deviation 0.43
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The eSCCIP Evaluation Questionnaire
eSCCIP helped me think differently about cancer.
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3.27 score on a scale
Standard Deviation 0.94
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The eSCCIP Evaluation Questionnaire
eSCCIP will help me help my child.
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3.43 score on a scale
Standard Deviation 0.77
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The eSCCIP Evaluation Questionnaire
I would recommend eSCCIP to other families.
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3.87 score on a scale
Standard Deviation 0.35
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The eSCCIP Evaluation Questionnaire
I was satisfied with eSCCIP.
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3.80 score on a scale
Standard Deviation 0.55
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SECONDARY outcome
Timeframe: Up to 9 weeksSingle-item indicator of psychosocial distress that is widely used in the oncology. Scores range from 1-10, with higher scores indicating more distress.
Outcome measures
| Measure |
eSCCIP
n=31 Participants
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: 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.
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Distress Thermometer
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4.03 score on a scale
Standard Deviation 2.54
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SECONDARY outcome
Timeframe: Up to 9 weeksQuestionnaire used to assess state anxiety. Total scores range from 0-21, with higher scores indicating increased anxiety symptom severity.
Outcome measures
| Measure |
eSCCIP
n=31 Participants
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: 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.
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Generalized Anxiety Disorder - 7 (GAD-7)
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3.81 score on a scale
Standard Deviation 3.89
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SECONDARY outcome
Timeframe: Up to 9 weeksQuestionnaire 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.
Outcome measures
| Measure |
eSCCIP
n=31 Participants
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: 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.
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SCORE-15
Total score
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14.74 score on a scale
Standard Deviation 5.26
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SCORE-15
Disrupted Communication Subscale
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3.03 score on a scale
Standard Deviation 2.11
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SCORE-15
Overwhelmed by Difficulties Subscale
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2.26 score on a scale
Standard Deviation 2.13
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SCORE-15
Strengths and Adaptability Subscale
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9.45 score on a scale
Standard Deviation 3.75
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
eSCCIP
n=31 Participants
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: 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.
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PTSD Checklist for DSM-5 (PCL-5)
PCL-5 sum score
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11.23 score on a scale
Standard Deviation 7.76
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PTSD Checklist for DSM-5 (PCL-5)
PCL-5 subscale B
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3.07 score on a scale
Standard Deviation 3.07
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PTSD Checklist for DSM-5 (PCL-5)
PCL-5 subscale C
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1.55 score on a scale
Standard Deviation 1.67
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PTSD Checklist for DSM-5 (PCL-5)
PCL-5 subscale D
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3.16 score on a scale
Standard Deviation 2.87
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PTSD Checklist for DSM-5 (PCL-5)
PCL-5 subscale E
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3.45 score on a scale
Standard Deviation 2.50
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SECONDARY outcome
Timeframe: Up to 9 weeks.Population: The CEFIS was added to the measure battery after the measure was created in response to the onset of the COVID-19 pandemic. As such, only the subset of patients who enrolled after the onset of the pandemic were administered the CEFIS.
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.
Outcome measures
| Measure |
eSCCIP
n=21 Participants
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: 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.
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The COVID-19 Exposure and Family Impact Scales (CEFIS)
CEFIS Exposure
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7.81 score on a scale
Standard Deviation 2.80
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The COVID-19 Exposure and Family Impact Scales (CEFIS)
CEFIS Impact
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2.60 score on a scale
Standard Deviation 0.62
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The COVID-19 Exposure and Family Impact Scales (CEFIS)
CEFIS Distress
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4.71 score on a scale
Standard Deviation 2.27
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Adverse Events
eSCCIP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place