- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03127254
Can Making Video Narratives Benefit Adolescents With Cancer
April 8, 2020 updated by: Case Comprehensive Cancer Center
The purpose of this study is to learn more about the content of and benefits of making video testimonials in adolescents with cancer.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
The current research aims to:
A. 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 Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video Narrative with surveys
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)
|
create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer
A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients
Other Names:
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
Other Names:
The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete
The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at end of intervention - Approximately 60 minutes after enrolling on study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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
|
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
|
at end of intervention - Approximately 60 minutes after enrolling on study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer C Anderson, PhD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 5, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
April 17, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 25, 2017
Study Record Updates
Last Update Posted (Actual)
April 9, 2020
Last Update Submitted That Met QC Criteria
April 8, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CASE12Z16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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