Pediatric CancerNCT03127254
Can Making Video Narratives Benefit Adolescents With Cancer
A study testing Video narrative, PedsQL and Ten Item Personality Inventory in people with Pediatric Cancer, run by Case Comprehensive Cancer Center.
Trial summary
The purpose of this study is to learn more about the content of and benefits of making video testimonials in adolescents with cancer. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Video narrative, PedsQL and Ten Item Personality Inventory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2020to Dec 2020
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with cancer
- Patients receiving cancer treatment for the first time
- Can complete study before high school graduation
- Must be able to read and understand English
Who cannot join
- Participants cannot have been treated for other chronic illnesses prior to cancer diagnosis
- Patients with cognitive and.or verbal capacities impaired to the point where they cannot consent or assent for themselves
- Patients who cannot communicate narratives clearly due to cognitive and/or verbal impairments
About this study
The purpose of this study is to learn more about the content of and benefits of making video testimonials in adolescents with cancer.
Read the detailed description
The current research aims to:
- enlist teens with cancer to produce video narratives about their experiences with their illness B. explicitly characterize and investigate the videos' content and C. determine what aspects of the production were helpful to the teen making them and predicted to be helpful to those watching them.
- Conditions
- Pediatric Cancer
- Being tested
- Video narrative, PedsQL, Ten Item Personality Inventory, Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, The Cognitive Log
- Keywords
- Video Narrative
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video narrativeBehavioural
create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer
PedsQLBehavioural
Also called Pediatric quality of life
A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients
Ten Item Personality InventoryBehavioural
Also called TIPI
The TIPI consists of ten items and measures personality based the subject's agreement of descriptions of themselves taken from the Big-5 model of personality
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency TestBehavioural
The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete
The Cognitive LogBehavioural
Also called Cog-Log
The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation
| Study group | Role | What they receive |
|---|---|---|
| Video Narrative with surveys | Experimental | Participants will be asked to create a 10-15 minute video narrative on their experiences after being diagnosed with cancer. Participants will also be asked to complete surveys including pediatric quality of life (PedsQL), Ten Item Personality Inventory (TIPI), Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, and The Cognitive Log (Cog-Log) Receives: Behavioral: Video narrative; Behavioral: PedsQL; Behavioral: Ten Item Personality Inventory; Behavioral: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test; Behavioral: The Cognitive Log |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear regression of pediatric quality of life (PedsQL), TIPI, and coded themes from video narratives on coherence, subjectivity and redemption
Participants' composite scores of the 10 items that make up the emotional and social domains from the PedsQL, 15 items from the PedsQL cancer module, and the two items on the TIPI that measure Extroversion will positively covary with the resilient qualities of their narrative as measured by levels of narrative coherence, subjectivity, and redemption
Measured: at end of intervention - Approximately 60 minutes after enrolling on study
Secondary outcomes (3)
linear regression of coded resilient qualities of narrative with Post Video Impression Questionnaire
Resilient qualities of the narrative, as measured by levels of narrative coherence, subjectivity, and redemption, will predict the sum of 16 select items on the Post Video Impressions Questionnaire identifying positive impact associated with producing the narrative
Measured: at end of intervention - Approximately 60 minutes after enrolling on study
linear regression of impact experienced from making the video narrative with summed scores of participants willingness to post online
The sum of the 16 item composite scale measuring impact experienced from making the testimonial video, on the Post Video Impressions Questionnaire, will positively predict the summed scores of two items measuring participants' willingness to post the video online
Measured: at end of intervention - Approximately 60 minutes after enrolling on study
linear regression of perceived impact with summed scores of participants willingness to post the video online
The sum of the 7 item composite scale measuring the perceived impact on others who watch the video, on the Post Video Impressions Questionnaire, will positively predict the summed scores of two items measuring participants' willingness to post the video online
Measured: at end of intervention - Approximately 60 minutes after enrolling on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start5 Mar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Research cancelled
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.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- MetroHealth Medical Center, Palo Alto University
- Responsible party
- Sponsor
- Investigators
- Jennifer C Anderson, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127254
- Sponsor's protocol ID
- CASE12Z16
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2017
- Last updated
- 9 Apr 2020
- 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 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Making Video Narratives Benefit Adolescents With Cancer
- ClinicalTrials.gov ID
- NCT03127254
- Acronym / sponsor ID
- CASE12Z16
- Conditions
- Pediatric Cancer
- Keywords
- Video Narrative
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- MetroHealth Medical Center, Palo Alto University
- Study start
- 5 Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Apr 2017 (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.
The purpose of this study is to learn more about the content of and benefits of making video testimonials in adolescents with cancer.
Detailed description
The current research aims to:
- enlist teens with cancer to produce video narratives about their experiences with their illness B. explicitly characterize and investigate the videos' content and C. determine what aspects of the production were helpful to the teen making them and predicted to be helpful to those watching them.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Narrative with surveys | Experimental | Behavioral: Video narrative, Behavioral: PedsQL, Behavioral: Ten Item Personality Inventory, Behavioral: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, Behavioral: The Cognitive LogParticipants will be asked to create a 10-15 minute video narrative on their experiences after being diagnosed with cancer. Participants will also be asked to complete surveys including pediatric quality of life (PedsQL), Ten Item Personality Inventory (TIPI), Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test, and The Cognitive Log (Cog-Log) |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with cancer
- Patients receiving cancer treatment for the first time
- Can complete study before high school graduation
- Must be able to read and understand English
Key exclusion criteria (3 listed)
- Participants cannot have been treated for other chronic illnesses prior to cancer diagnosis
- Patients with cognitive and.or verbal capacities impaired to the point where they cannot consent or assent for themselves
- Patients who cannot communicate narratives clearly due to cognitive and/or verbal impairments
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 |
|---|---|---|
| Video narrativecreate a 10-15 minute video intervention about teen experiences after being diagnosed with cancer | Behavioural | Video Narrative with surveys |
| PedsQLAlso: Pediatric quality of lifeA generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients | Behavioural | Video Narrative with surveys |
| Ten Item Personality InventoryAlso: TIPIThe TIPI consists of ten items and measures personality based the subject's agreement of descriptions of themselves taken from the Big-5 model of personality | Behavioural | Video Narrative with surveys |
| Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency TestThe D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete | Behavioural | Video Narrative with surveys |
| The Cognitive LogAlso: Cog-LogThe Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation | Behavioural | Video Narrative with surveys |
Primary outcome
linear regression of pediatric quality of life (PedsQL), TIPI, and coded themes from video narratives on coherence, subjectivity and redemption
Time frame: at end of intervention - Approximately 60 minutes after enrolling on study
Participants' composite scores of the 10 items that make up the emotional and social domains from the PedsQL, 15 items from the PedsQL cancer module, and the two items on the TIPI that measure Extroversion will positively covary with the resilient qualities of their narrative as measured by levels of narrative coherence, subjectivity, and redemption
3 secondary outcomes
linear regression of coded resilient qualities of narrative with Post Video Impression Questionnaire
Time frame: at end of intervention - Approximately 60 minutes after enrolling on study
linear regression of impact experienced from making the video narrative with summed scores of participants willingness to post online
Time frame: at end of intervention - Approximately 60 minutes after enrolling on study
linear regression of perceived impact with summed scores of participants willingness to post the video online
Time frame: at end of intervention - Approximately 60 minutes after enrolling on study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
Jennifer C Anderson, PhD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Video narrative, PedsQL and Ten Item Personality Inventory in people with Pediatric Cancer, run by Case Comprehensive Cancer Center.
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 4 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: withdrawn, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
linear regression of pediatric quality of life (PedsQL), TIPI, and coded themes from video narratives on coherence, subjectivity and redemption (time frame: at end of intervention - Approximately 60 minutes after enrolling on study). 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 9 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.