Pediatric CancerALSFNCT05051800
Enhancing Coping and Communication in Children With Cancer and Their Parents
A study testing Online Program to Support Coping and Communication in Families in people with Pediatric Cancer, run by Vanderbilt University at 1 site in United States.
Trial summary
Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Online Program to Support Coping and Communication in Families
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child from ages 10 to 17 years old who has been diagnosed with cancer
Who cannot join
- Significant intellectual disability that would interfere with completing the online program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Coping and Communication in Children With Cancer and Their Parents: A Novel Internet Intervention
Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.
Read the detailed description
Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. This online program includes modules to teach parenting, communication and coping skills to parents of children with cancer, and coping skills to their children who have been recently diagnosed with cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.
- Conditions
- Pediatric Cancer
- Being tested
- Online Program to Support Coping and Communication in Families
- Keywords
- Pediatric cancer, Coping
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Program to Support Coping and Communication in FamiliesBehavioural
Parents and children will access online materials designed to support the use of effective ways to cope with the diagnosis and treatment of cancer and to support open and communication.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | Families will receive the online program to support coping and communication near the time of a child's cancer diagnosis Receives: Behavioral: Online Program to Support Coping and Communication in Families |
| Delayed Intervention | Active comparator | Families will receive the online program to support coping and communication approximately 6 months after a child's cancer diagnosis Receives: Behavioral: Online Program to Support Coping and Communication in Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Behavior Problems on the Child Behavior Checklist from baseline to 6 months
Change in parents' report on the Child Behavior Checklist (a measure of their children's total emotional and behavioral problems).
Measured: The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups
Change in Total Behavior Problems on the Youth Self Report from baseline to 6 months
Change in children's report on the Youth Self Report (a measure of their children's total emotional and behavioral problems).
Measured: This measure will be completed near the time of entry into the study and repeated at 6 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Feb 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Recruitment of participants was interrupted by the COVID-19 pandemic and the funding for the study ended before the targeted enrollment could be completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Model description
- Recruitment and randomization of participants into an online support program vs. usual care. Participants in the usual care condition offered the program after 6 months.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Bruce Compas, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051800
- Sponsor's protocol ID
- IRB 170111
- Acronym
- ALSF
- Status last verified
- Sep 2021
- First submitted
- 18 Jun 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Coping and Communication in Children With Cancer and Their Parents: A Novel Internet Intervention
- ClinicalTrials.gov ID
- NCT05051800
- Acronym / sponsor ID
- ALSF / IRB 170111
- Conditions
- Pediatric Cancer
- Keywords
- Pediatric cancer, Coping
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of participants was interrupted by the COVID-19 pandemic and the funding for the study ended before the targeted enrollment could be completed.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Sep 2021 (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.
Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.
Detailed description
Childhood cancer patients and their parents are faced with significant stress at the time of diagnosis, during treatment, and over the course of recovery. The stress of cancer and its treatment can lead to significant emotional distress for many families. However, most families do not have access to programs that offer support for coping with cancer-related stress. The proposed work will address this gap by testing of the possible benefits of a novel internet delivered program to support children with cancer and their parents in coping with and communicating about a child's cancer. This online program includes modules to teach parenting, communication and coping skills to parents of children with cancer, and coping skills to their children who have been recently diagnosed with cancer. The research team includes experts from Vanderbilt University and Nationwide Children's Hospital with experience in pediatric oncology; stress, coping, and family communication in pediatric cancer; internet interventions in pediatric populations; and family-focused interventions to build coping and parenting skills. The study will test the effects of this program in 150 families of children with newly diagnosed cancer on reducing emotional distress up to 12 months after participation in the program. This project has the potential to lead to an evidence-based program to improve quality of life and resilience in children with cancer and their parents that can be easily and widely disseminated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Recruitment and randomization of participants into an online support program vs. usual care. Participants in the usual care condition offered the program after 6 months.
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Behavioral: Online Program to Support Coping and Communication in FamiliesFamilies will receive the online program to support coping and communication near the time of a child's cancer diagnosis |
| Delayed Intervention | Active comparator | Behavioral: Online Program to Support Coping and Communication in FamiliesFamilies will receive the online program to support coping and communication approximately 6 months after a child's cancer diagnosis |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child from ages 10 to 17 years old who has been diagnosed with cancer
Key exclusion criteria (1 listed)
- Significant intellectual disability that would interfere with completing the online program
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 |
|---|---|---|
| Online Program to Support Coping and Communication in FamiliesParents and children will access online materials designed to support the use of effective ways to cope with the diagnosis and treatment of cancer and to support open and communication. | Behavioural | Delayed Intervention, Early Intervention |
Primary outcome
Change in Total Behavior Problems on the Child Behavior Checklist from baseline to 6 months
Time frame: The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups
Change in parents' report on the Child Behavior Checklist (a measure of their children's total emotional and behavioral problems).
Change in Total Behavior Problems on the Youth Self Report from baseline to 6 months
Time frame: This measure will be completed near the time of entry into the study and repeated at 6 month follow ups
Change in children's report on the Youth Self Report (a measure of their children's total emotional and behavioral problems).
Results and safety
The study was stopped early (reason given: Recruitment of participants was interrupted by the COVID-19 pandemic and the funding for the study ended before the targeted enrollment could be completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Program to Support Coping and Communication in Families in people with Pediatric Cancer, run by Vanderbilt University 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 1 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: stopped early, as of the sponsor's last update on 21 Sep 2021. 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?
The study was stopped early (reason given: Recruitment of participants was interrupted by the COVID-19 pandemic and the funding for the study ended before the targeted enrollment could be completed.). Results are not available in the source record.
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?
Change in Total Behavior Problems on the Child Behavior Checklist from baseline to 6 months (time frame: The Child Behavior Checklist will be completed near the time of entry into the study and repeated at 6 month follow ups). The study lists 2 primary outcomes in all. 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 21 Sep 2021.