Malignant NeoplasmPhase 1NCT03677531
Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy
A Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2018to 25 Sep 2019
- Phase
- 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 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All races and genders will be included.
- Patients with all tumor types will be included.
Who cannot join
- Patients < 3 years and > 13 years of age will be excluded.
- Patients with underlying movement disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT.
SECONDARY OBJECTIVE:
- To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder [ADHD], dissociative disorders [DD], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10).
EXPLORATORY OBJECTIVES:
- To determine the impact of VidRT on patient-reported quality of life prior to starting, during, and at the end of treatment using the pediatric quality of life inventory surveys including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain tumor questionnaires.
II. To determine the impact of VidRT on patient-reported anxiety throughout radiation treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item bank version (v) 2.0 anxiety questionnaire.
III. To determine if workup assessment category for patient being low, medium, or high risk of needing sedation correlates to actual sedation use.
OUTLINE:
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
- Conditions
- Malignant Neoplasm
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Radiation Therapy, Video
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, Irradiated, Irradiation
Undergo RT
VideoOther
Watch video of choice during RT
| Study group | Role | What they receive |
|---|---|---|
| Other (radiation therapy, videos) | Experimental | Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Other: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sedation use calculated using number of treatment sessions
A 1-sided binomial test will be used.
Measured: Up to 1 year
Secondary outcomes (7)
Patient age and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Number of treatments and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Beam "on-time" and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use
Measured: Up to 1 year
Oncologic diagnosis and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Use of immobilization device and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)
A multivariate analysis will be used to determine which variables correlate with increased sedation use.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start31 May 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Responsible party
- Principal investigator, Jerry Jaboin, OHSU Knight Cancer Institute
- Investigators
- Jerry J Jaboin, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677531
- Sponsor's protocol ID
- STUDY00018053
- Other IDs
- NCI-2018-01505, STUDY00018053, P30CA069533
- Status last verified
- Apr 2020
- First submitted
- 14 Sep 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
- ClinicalTrials.gov ID
- NCT03677531
- Acronym / sponsor ID
- STUDY00018053
- Conditions
- Malignant Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 31 May 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 19 Sep 2018 (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.
This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.
Detailed description
PRIMARY OBJECTIVE:
- To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT.
SECONDARY OBJECTIVE:
- To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder [ADHD], dissociative disorders [DD], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10).
EXPLORATORY OBJECTIVES:
- To determine the impact of VidRT on patient-reported quality of life prior to starting, during, and at the end of treatment using the pediatric quality of life inventory surveys including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain tumor questionnaires.
II. To determine the impact of VidRT on patient-reported anxiety throughout radiation treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item bank version (v) 2.0 anxiety questionnaire.
III. To determine if workup assessment category for patient being low, medium, or high risk of needing sedation correlates to actual sedation use.
OUTLINE:
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other (radiation therapy, videos) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation Therapy, Other: VideoParticipants undergo daily radiation therapy and watch videos/movies of their choice during treatments. |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All races and genders will be included.
- Patients with all tumor types will be included.
Key exclusion criteria (2 listed)
- Patients < 3 years and > 13 years of age will be excluded.
- Patients with underlying movement disorders will be excluded.
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Other (radiation therapy, videos) |
| Questionnaire AdministrationAncillary studies | Other | Other (radiation therapy, videos) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, Irradiated, IrradiationUndergo RT | Radiation | Other (radiation therapy, videos) |
| VideoWatch video of choice during RT | Other | Other (radiation therapy, videos) |
Primary outcome
Rate of sedation use calculated using number of treatment sessions
Time frame: Up to 1 year
A 1-sided binomial test will be used.
7 secondary outcomes
Patient age and association with decreased sedation use
Time frame: Up to 1 year
Number of treatments and association with decreased sedation use
Time frame: Up to 1 year
Beam "on-time" and association with decreased sedation use
Time frame: Up to 1 year
Oncologic diagnosis and association with decreased sedation use
Time frame: Up to 1 year
Use of immobilization device and association with decreased sedation use
Time frame: Up to 1 year
Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use
Time frame: Up to 1 year
Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)
Time frame: Up to 1 year
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 4 May 2020.
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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.
Jerry J Jaboin principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Therapy in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute 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 2 inclusion and 2 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 4 May 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Rate of sedation use calculated using number of treatment sessions (time frame: Up to 1 year). 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 4 May 2020.