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Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793299
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):
Barbara Asselin, University of Rochester

Tracking Information
First Submitted Date  ICMJE November 18, 2008
First Posted Date  ICMJE November 19, 2008
Last Update Posted Date April 27, 2015
Study Start Date  ICMJE November 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Memorial Symptom Assessment Scale [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Rosenberg Self Esteem Scale [ Time Frame: 3 mopnths ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
Official Title  ICMJE Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
Brief Summary In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.
Detailed Description

In addition to the above outcome measures:

The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Behavioral: Video Illness Narrative
video
Study Arms  ICMJE Experimental: Video Illness Narrative
single arm pilot study
Intervention: Behavioral: Video Illness Narrative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
15
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with cancer
  • Age 10-18
  • In active treatment for cancer
  • Followed at the Strong Memorial Hospital/Golisano Children's Hospital

Exclusion Criteria:

  • Non-English Speaker
  • Cognitively impaired so as to make data collection difficult
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793299
Other Study ID Numbers  ICMJE RSRB00025699
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barbara Asselin, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily Hahn, BA Medical Student
Principal Investigator: Barbara Asselin, MD Associate Professor
PRS Account University of Rochester
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP