Actively Undergoing Cancer TreatmentNCT02611739
Medi-Port Pilot Randomized Controlled Trial
A study testing Medi-Port in people with Actively Undergoing Cancer Treatment and 4-9 Years of Age, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Actively Undergoing Cancer Treatment, 4-9 Years of Age, At Least 1 Month From Diagnosis
- What is being tested?
- Medi-Port
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2016
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-9 years
- able to speak and understand English,
- actively undergoing cancer treatment
- presenting to clinic for at least a 2nd subcutaneous port needle insertion
- being at least 1 month from diagnosis.
Who cannot join
- visual, auditory or cognitive impairments precluding interaction with Medi-Port
- end-of-life patients
- patients who are nil per os pre-sedation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial
Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. Our research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.
Read the detailed description
A sample of 40 children with cancer between the ages of 4-9 years (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. The feasibility of the trial protocol to evaluate the impact of distraction via the humanoid robot on pain intensity and distress during SCP needle insertion compared to an active control in children with cancer will be explored. The effectiveness outcome includes the examination of the robot programmed to distract children during the procedure, reduce pain intensity and distress compared to an active control intervention (i.e. dancing robot).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medi-PortDevice
Treatment
Medi-PortDevice
Control
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Children in the experimental treatment condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a pre-programmed series of behaviours to distract the child before, during, and after the SCP needle insertion. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., "What's on TV?"). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. Receives: Device: Medi-Port |
| Control Group | Active comparator | Following consent and randomization, children in the (control) usual care condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a standard set of dancing movements only. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., "What's on TV?"). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. Receives: Device: Medi-Port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rates
Accrual rates will be captured by recording data related to the number of eligible children per recruitment day, reasons for ineligibility, and reasons for non-participation.
Measured: 12 months
Acceptability
Acceptability will be measured using the Medi-Port Satisfaction Questionnaire completed by children, parent, and nurses that will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
Measured: 12 months
Outcome measure feasibility
Outcome measure feasibility will be measured as the percentage of completed outcome measures at baseline and study completion (100% when all questionnaires are completed) and will be recorded on Medi-Port Activity Log.
Measured: 12 months
Technical difficulties
Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Measured: 12 months
Practical difficulties
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Measured: 12 months
Time
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Measured: 12 months
Secondary outcomes (2)
Pain intensity
Pain intensity (both retrospectively for previous SCP access and after the study procedures) will be measured. Children will self-report their pain and parents, nurses, and the researcher will use proxy-reporting in rating children's pain. Children will use the Faces Pain Scale-Revised (FPS-R) which has been validated in children 4 years and older. Parents, nurses, and the researcher will use an 11-point numerical rating scale (NRS), with verbal anchors of "no pain at all" at 0 and "the most pain you can imagine this child having" at 10.
Measured: 12 months
Distress
Distress (both retrospectively for previous SCP access and after the study procedures will be measured). Children will retrospectively report fear using the Children's Fear Scale (CFS), which is a visual scale with established psychometrics in children 5-10 years. Parents will retrospectively report pain using an 11-point NRS. Distress during the study SCP access will be measured using the observer-rated Behavioral Approach-Avoidance Scale (BAADS). The same 2 trained research team members will code video-recordings from all SCP needle insertions using the BAADS. Child distress behaviours will be scored at specific steps during the procedure: 1) nurse movement towards the child 2) pre-procedure skin sterilization 3) SCP position assessment by nurse 4) needle insertion 5) sterile dressing application.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actively Undergoing Cancer TreatmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Jennifer Stinson, The Hospital for Sick Children
- Investigators
- Jennifer Stinson, RN, PhD, Principal investigator, The Hospital for Sick ChildrenPaul Nathan, MD, Principal investigator, The Hospital for Sick ChildrenTanya Beran, PhD, RPsych, Principal investigator, University of CalgaryLindsay Jibb, RN, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611739
- Sponsor's protocol ID
- 1000049494
- Status last verified
- Dec 2017
- First submitted
- 19 Nov 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jibb LA, Birnie KA, Nathan PC, Beran TN, Hum V, Victor JC, Stinson JN. Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial. Pediatr Blood Cancer. 2018 Sep;65(9):e27242. doi: 10.1002/pbc.27242. Epub 2018 Jun 12.
PubMed 29893482
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02611739
- Acronym / sponsor ID
- 1000049494
- Conditions
- Actively Undergoing Cancer Treatment, 4-9 Years of Age, At Least 1 Month From Diagnosis, Able to Speak and Understand English, Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Nov 2015 (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.
Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. Our research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.
Detailed description
A sample of 40 children with cancer between the ages of 4-9 years (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. The feasibility of the trial protocol to evaluate the impact of distraction via the humanoid robot on pain intensity and distress during SCP needle insertion compared to an active control in children with cancer will be explored. The effectiveness outcome includes the examination of the robot programmed to distract children during the procedure, reduce pain intensity and distress compared to an active control intervention (i.e. dancing robot).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Medi-PortChildren in the experimental treatment condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a pre-programmed series of behaviours to distract the child before, during, and after the SCP needle insertion. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., "What's on TV?"). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. |
| Control Group | Active comparator | Device: Medi-PortFollowing consent and randomization, children in the (control) usual care condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a standard set of dancing movements only. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., "What's on TV?"). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 4-9 years
- able to speak and understand English,
- actively undergoing cancer treatment
- presenting to clinic for at least a 2nd subcutaneous port needle insertion
- being at least 1 month from diagnosis.
Key exclusion criteria (3 listed)
- visual, auditory or cognitive impairments precluding interaction with Medi-Port
- end-of-life patients
- patients who are nil per os pre-sedation.
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 |
|---|---|---|
| Medi-PortTreatment | Device | Intervention Group |
| Medi-PortControl | Device | Control Group |
Primary outcome
Accrual rates
Time frame: 12 months
Accrual rates will be captured by recording data related to the number of eligible children per recruitment day, reasons for ineligibility, and reasons for non-participation.
Acceptability
Time frame: 12 months
Acceptability will be measured using the Medi-Port Satisfaction Questionnaire completed by children, parent, and nurses that will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
Outcome measure feasibility
Time frame: 12 months
Outcome measure feasibility will be measured as the percentage of completed outcome measures at baseline and study completion (100% when all questionnaires are completed) and will be recorded on Medi-Port Activity Log.
Technical difficulties
Time frame: 12 months
Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Practical difficulties
Time frame: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Time
Time frame: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
2 secondary outcomes
Pain intensity
Time frame: 12 months
Distress
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Derived from this study: PubMed 29893482Jibb LA, Birnie KA, Nathan PC, Beran TN, Hum V, Victor JC, Stinson JN. Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial. Pediatr Blood Cancer. 2018 Sep;65(9):e27242. doi: 10.1002/pbc.27242. Epub 2018 Jun 12.
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.
Jennifer Stinson, RN, PhD principal investigator
The Hospital for Sick Children
Paul Nathan, MD principal investigator
The Hospital for Sick Children
Tanya Beran, PhD, RPsych principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medi-Port in people with Actively Undergoing Cancer Treatment and 4-9 Years of Age, run by The Hospital for Sick Children at 1 site in Canada.
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 5 inclusion and 3 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 3 Jan 2018. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accrual rates (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611739, which also lists 1 linked publication.
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 Jan 2018.