NCT03127254

Brief Summary

The purpose of this study is to learn more about the content of and benefits of making video testimonials in adolescents with cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 17, 2017

Last Update Submit

April 8, 2020

Conditions

Keywords

Video Narrative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • linear regression of coded resilient qualities of narrative with Post Video Impression Questionnaire

    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

    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

    at end of intervention - Approximately 60 minutes after enrolling on study

Study Arms (1)

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)

Behavioral: Video narrativeBehavioral: PedsQLBehavioral: Ten Item Personality InventoryBehavioral: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency TestBehavioral: The Cognitive Log

Interventions

Video narrativeBEHAVIORAL

create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer

Video Narrative with surveys
PedsQLBEHAVIORAL

A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients

Also known as: Pediatric quality of life
Video Narrative with surveys

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

Also known as: TIPI
Video Narrative with surveys

The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete

Video Narrative with surveys

The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation

Also known as: Cog-Log
Video Narrative with surveys

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Jennifer C Anderson, PhD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 25, 2017

Study Start

March 5, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 9, 2020

Record last verified: 2020-04