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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03127254
Other study ID # CASE12Z16
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 5, 2020
Est. completion date December 2020

Study information

Verified date April 2020
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video narrative
create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer
PedsQL
A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients
Ten Item Personality Inventory
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 Test
The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete
The Cognitive Log
The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center MetroHealth Medical Center, Palo Alto University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at end of intervention - Approximately 60 minutes after enrolling on study
Secondary 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 at end of intervention - Approximately 60 minutes after enrolling on study
Secondary 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 at end of intervention - Approximately 60 minutes after enrolling on study
Secondary 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 at end of intervention - Approximately 60 minutes after enrolling on study
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