Any Cancer DiagnosisEarly Phase 1NCT01704885
A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer
A Early Phase 1 study testing Play Intervention and Questionnaires in people with Any Cancer Diagnosis, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Any Cancer Diagnosis
- What is being tested?
- Play Intervention and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2015
- Phase
- Early Phase 1
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families who have had children diagnosed with any type of cancer in the past year.
- At least one sibling between the ages of 4 and 10 years old
- Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.
Read the detailed description
Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.
- Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms.
- Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms.
Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.
- Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
- Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
- Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention.
Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").
- Conditions
- Any Cancer Diagnosis
- Being tested
- Play Intervention, Questionnaires
- Keywords
- Childhood Cancer, Sibling Play intervention, Sibling Behavioral Intervention, Siblings of Cancer Patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play InterventionBehavioural
Also called Story Stems to play out, Problem solving, positive self-statements, make up a story
QuestionnairesOther
Also called Demographic questionnaire, Parent/Well-Sibling Communication Measure, BASC-2 (Behavior Assessment System for Children-Second Edition), RSQ (Response to Stress Questionnaire)
| Study group | Role | What they receive |
|---|---|---|
| Active Control Group | Sham comparator | Children in the active control group will play with puzzles, a building toy, or color. The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult. Receives: Other: Questionnaires |
| Play Intervention | Experimental | children in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts). The play facilitator will play with the child, modeling and praising use of positive coping skills. In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session. The child will be allowed to make up a story about whatever they want before ending each session. Receives: Behavioral: Play Intervention; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with increase in coping skills after intervention
Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
Measured: 4 weeks
Number of children with better psychological adjustment following intervention
Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
Measured: 4 weeks
Number of parents with decreased parenting stress following intervention
Parents of children in the play intervention group will report decreased parenting stress following the intervention.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karla Fehr, M.A., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704885
- Sponsor's protocol ID
- CASE4Z11
- Other IDs
- CC00130
- Status last verified
- Jul 2015
- First submitted
- 9 Oct 2012
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive- Behavioral Play Intervention for Siblings of Children Diagnosed With Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT01704885
- Acronym / sponsor ID
- CASE4Z11
- Conditions
- Any Cancer Diagnosis
- Keywords
- Childhood Cancer, Sibling Play intervention, Sibling Behavioral Intervention, Siblings of Cancer Patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Oct 2012 (estimated)
- 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.
The goal of this study is to determine whether a brief (three 20-30 minute session) cognitive-behavioral play intervention will improve coping skills and adjustment for siblings of children diagnosed with cancer.
Detailed description
Aim 1: Assess baseline adjustment, coping, pretend play, parenting stress, and family interactions.
- Hypothesis 1a: Children with siblings diagnosed with cancer will have lower levels of adjustment, coping skills, and pretend play compared to previous sample norms.
- Hypothesis 1b: The child's adjustment will be mediated by factors related to their involvement in the sibling's medical care, such as parent's level of communication regarding their sibling's illness, frequent isolation from the family and other social support, time since their sibling's diagnosis, and parenting stress. -Hypothesis 1c: Parents of children diagnosed with cancer will report higher levels of parenting stress compared to previous sample norms.
Aim 2: Assess outcome of three play intervention sessions focusing on increasing coping and adjustment.
- Hypothesis 2a: Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
- Hypothesis 2b: Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
- Hypothesis 2c: Parents of children in the play intervention group will report decreased parenting stress following the intervention.
Once parents consent to participate and their child provides assent, they and their child will complete the baseline questionnaires and measures. Immediately following completion of the baseline measures, the child will be randomly assigned to either the play intervention or active control group.Children will also be asked to rate their mood at the beginning of each play session. The outcome parent and child questionnaires will be administered again at a session approximately one week after the third play session, for a total of four play sessions each spaced approximately one week apart. Children will also be asked to rate their satisfaction with the treatment at the outcome session (e.g., "How much did you like being a part of this study?").
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control Group | Sham comparator | Other: QuestionnairesChildren in the active control group will play with puzzles, a building toy, or color. The play facilitator will praise the child and interact at a similar rate to control for interaction with a caring adult. |
| Play Intervention | Experimental | Behavioral: Play Intervention, Other: Questionnaireschildren in the play intervention group will be given 3 story stems that they are asked to play out with the goal of helping the main character "feel better" (see session scripts). The play facilitator will play with the child, modeling and praising use of positive coping skills. In the first session the play facilitator will focus on positive self-statements, in the second session the play facilitator will focus on problem-solving, and a combination of these two approaches will be used in the final session. The child will be allowed to make up a story about whatever they want before ending each session. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Families who have had children diagnosed with any type of cancer in the past year.
- At least one sibling between the ages of 4 and 10 years old
- Patients will be targeted 1-2 months after diagnosis, but could be included in the study up to 12 months following diagnosis.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Play InterventionAlso: Story Stems to play out, Problem solving, positive self-statements, make up a story | Behavioural | Play Intervention |
| QuestionnairesAlso: Demographic questionnaire, Parent/Well-Sibling Communication Measure, BASC-2 (Behavior Assessment System for Children-Second Edition), RSQ (Response to Stress Questionnaire) | Other | Active Control Group, Play Intervention |
Primary outcome
Number of children with increase in coping skills after intervention
Time frame: 4 weeks
Compared to the active control, children in the play intervention group will have increased coping skills after intervention.
Number of children with better psychological adjustment following intervention
Time frame: 4 weeks
Compared to the active control, children in the play intervention group will have better psychological adjustment following intervention.
Number of parents with decreased parenting stress following intervention
Time frame: 4 weeks
Parents of children in the play intervention group will report decreased parenting stress following the intervention.
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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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.
Karla Fehr, M.A. principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Play Intervention and Questionnaires in people with Any Cancer Diagnosis, run by Case Comprehensive Cancer Center 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: stopped early, as of the sponsor's last update on 3 Aug 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual). 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?
Number of children with increase in coping skills after intervention (time frame: 4 weeks). The study lists 3 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 3 Aug 2015.