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Improving Quality and Consistency in Family Education Prior to First Discharge Following Pediatric Cancer Diagnosis

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ClinicalTrials.gov Identifier: NCT03752801
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Pediatric Oncology Group of Ontario
Information provided by (Responsible Party):
Denise Mills, The Hospital for Sick Children

Brief Summary:
When a child is diagnosed with cancer the family's world is turned upside down. Parents have high levels of stress because they must learn important information about their child's diagnosis,medications and treatments. They must also learn how to care for their child once they have left the safety of the hospital. Parents have voiced that during this time they receive too much information, have paper overload, and hear and read different information causing them to feel confused. Parents have shared that small amounts of information that can be repeated when they want and as often as they want helps them to feel more confident to care for their child. This study will ask parents if they like and can easily learn information about how to care for their child with cancer from short videos that highlight key points, have visual cues, and provide case examples. If parents find short videos useful and helpful for learning, with the goal that they will feel more confident to care for their child and have lower levels of anxiety.

Condition or disease
Oncology

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Quality and Consistency in Family Education Prior to First Discharge Following Pediatric Cancer Diagnosis
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort
Script Review Parents/Caregivers
will have script reviewed and evaluated by parents/caregivers in groups of 5 up to 40 participants until 4/5 parents/caregivers demonstrate that script is understandable and acceptable.
Video Review Parents/Caregivers
review and evaluation of the developed educational videos by parents/caregivers up to 20 parents who have not participated in the script review



Primary Outcome Measures :
  1. Measure acceptability and ability to understand video-based education modules for parent/caregivers of children with newly diagnosed cancer [ Time Frame: parents will watch video one (approx. 10 minutes) ]
    Develop 2 short video-based education modules for parents/caregivers of children with newly diagnosed cancer which are acceptable and understandable. This will be achieved when 90% of enrolled parents/caregivers watch the two videos and correctly answer 10 knowledge and confidence questions.


Secondary Outcome Measures :
  1. Measure the feasibility of providing video to families [ Time Frame: parents will watch video one (approx. 10 minutes) ]
    The feasibility of a trial of providing education in video modules as demonstrated by the ability to recruit 20 parents/caregivers of newly diagnosed children

  2. Qualitative feedback about the videos [ Time Frame: parents will watch video one (approx. 10 minutes) ]
    To obtain qualitative feedback about the videos

  3. Measure a change in knowledge and confidence before/after video [ Time Frame: parents will watch video one (approx. 10 minutes) asked questions before the video and same questions at end of video ]
    To measure a change in knowledge and confidence before and after viewing the two videos. Scores on the knowledge and confidence questions will be compared before watching and after watching the videos.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
parents or caregivers of children diagnosed with cancer
Criteria

Inclusion Criteria:

  • for the first phase - review of script, eligible respondents will be any parent or caregiver of a child with cancer irrespective of type of timing of diagnosis.
  • for the video review phase - must be a parent/caregiver of a child diagnosed with cancer in the last 8 months

Exclusion Criteria:

  • must have written and spoken English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752801


Contacts
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Contact: Mills 416 813-7654 ext 202629 denise.mills@sickkids.ca
Contact: Sue Zupanec sue.zupanec@sickkids.ca

Locations
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Canada, Ontario
Sickkids Recruiting
Toronto, Ontario, Canada
Contact: Denise Mills    4167665942    denise.mills@sickkids.ca   
Contact: Sadie Cook       sadie.cook@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Pediatric Oncology Group of Ontario
Investigators
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Principal Investigator: Denise Mills The Hospital for Sick Children

Publications:

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Responsible Party: Denise Mills, Nurse Practitioner, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03752801     History of Changes
Other Study ID Numbers: REB1000060860
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denise Mills, The Hospital for Sick Children:
education
pediatric
family
Additional relevant MeSH terms:
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Neoplasms