Pediatric CancerNCT05333601
An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
A study testing eSCCIP in people with Pediatric Cancer, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
Who cannot join
- Potential participants 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
1 site in 1 country.
United States1 site
Nemours Children's Health
Wilmington, Delaware, 19803
About this study
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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- eSCCIP
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSCCIPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: eSCCIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks.
Secondary outcomes (5)
Distress Thermometer
Single-item indicator of psychosocial distress that is widely used in the oncology. Scores range from 1-10, with higher scores indicating more distress.
Measured: Up to 9 weeks
Generalized Anxiety Disorder - 7 (GAD-7)
Questionnaire used to assess state anxiety. Total scores range from 0-21, with higher scores indicating increased anxiety symptom severity.
Measured: Up to 9 weeks
SCORE-15
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.
Measured: Up to 9 weeks
PTSD Checklist for DSM-5 (PCL-5)
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.
Measured: Up to 9 weeks.
The COVID-19 Exposure and Family Impact Scales (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.
Measured: Up to 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jan 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pilot study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
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
- Investigators
- Kimberly Canter, PhD, Principal investigator, Nemours Children's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333601
- Sponsor's protocol ID
- 5R03CA235002
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2022
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An eHealth Psychosocial Intervention for Caregivers of Children With Cancer
- ClinicalTrials.gov ID
- NCT05333601
- Acronym / sponsor ID
- 5R03CA235002
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 19 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pilot study
| Arm | Type | Receives |
|---|---|---|
| eSCCIP | Experimental | Behavioral: eSCCIPThe 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. |
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.
- Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).
Key exclusion criteria (1 listed)
- Potential participants 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 |
|---|---|---|
| eSCCIPThe 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. | Behavioural | eSCCIP |
Primary outcome
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.
5 secondary outcomes
Distress Thermometer
Time frame: Up to 9 weeks
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: Up to 9 weeks
SCORE-15
Time frame: Up to 9 weeks
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Up to 9 weeks.
The COVID-19 Exposure and Family Impact Scales (CEFIS)
Time frame: Up to 9 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kimberly Canter, PhD principal investigator
Nemours Children's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSCCIP in people with Pediatric Cancer, run by Nemours Children's Clinic at 1 site 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: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eSCCIP Evaluation Questionnaire (time frame: Up to 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2024.