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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Behavioral: Video narrative
create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer
Behavioral: PedsQL
A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients
Other Names:
  • Pediatric quality of life
Behavioral: 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
Other Names:
  • TIPI
Behavioral: 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
Behavioral: The Cognitive Log
The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation
Other Names:
  • Cog-Log

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Case Comprehensive Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MetroHealth Medical Center
Palo Alto University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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