Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01477255
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2011-11-15
Brief Title:
The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population A Pilot Study
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIARY1
Brief Summary:
This investigation seeks to determine the feasibility of an electronic diary methodology among pediatric cancer patients and healthy matched controls Levels of study participation and compliance will be assessed to assist with determining overall feasibility Results will offer insight into the effectiveness of this means of data collection with a pediatric oncology population and will examine how psychosocial and contextual factors contribute to the resiliency that has been demonstrated by children with cancer Findings will provide data for the design and implementation of a future larger-scale study with this pediatric population that implements an electronic daily diary methodology
Detailed Description:
The study will include two phases of participant recruitment and participation Phase I will include recruitment of six pediatric patients to pilot an electronic daily diary on an Apple iPad These participants will be prompted by the iPad once daily for seven days and will be asked to answer multiple choice and yesno questions related to their daily experiences activities and emotions Following the week of daily diary completion each participant in Phase I will engage in a brief feedback interview with a member of the research team to discuss hisher overall experiences using the electronic diary including any technological issues that arise The purpose of Phase I is to work out any technological andor logistical problems associated with completion of the daily iPad diary
After any technological problems have been addressed Phase II of the study will begin Child participants in Phase II of the study will complete several paper and pencil questionnaires on two separate occasions that assess factors including optimism experience of various emotions spirituality relationships with others benefit-finding quality of life and resiliency Children will also complete two weeks of daily electronic diaries that will prompt them to answer multiple choice and yesno questions related to their daily experiences activities and emotions One parent or guardian will also be recruited to participate and will complete paper and pencil questionnaires on two separate occasions that ask about optimism the parent-child relationship spirituality psychological functioning and their perceptions of their childrens behavior and mood
Finally following the completion of the first week of daily diaries a short interview will be conducted with each child and parent dyad to gather information about the childs experiences using the electronic diary They will be asked to provide feedback about any challenges and technological difficulties that they encountered as well as their general thoughts about using the electronic diary The interview will also include an opportunity to trouble-shoot difficulties associated with using the electronic daily diary in preparation for the second week of diary completion For each participant we anticipate a participation timeframe of 10-15 weeks
Primary Objective
To evaluate the usefulness of an electronic daily diary for understanding the experiences emotions and coping strategies of children with cancer and of their healthy peers
After any technological problems have been addressed Phase II of the study will begin Child participants in Phase II of the study will complete several paper and pencil questionnaires on two separate occasions that assess factors including optimism experience of various emotions spirituality relationships with others benefit-finding quality of life and resiliency Children will also complete two weeks of daily electronic diaries that will prompt them to answer multiple choice and yesno questions related to their daily experiences activities and emotions One parent or guardian will also be recruited to participate and will complete paper and pencil questionnaires on two separate occasions that ask about optimism the parent-child relationship spirituality psychological functioning and their perceptions of their childrens behavior and mood
Finally following the completion of the first week of daily diaries a short interview will be conducted with each child and parent dyad to gather information about the childs experiences using the electronic diary They will be asked to provide feedback about any challenges and technological difficulties that they encountered as well as their general thoughts about using the electronic diary The interview will also include an opportunity to trouble-shoot difficulties associated with using the electronic daily diary in preparation for the second week of diary completion For each participant we anticipate a participation timeframe of 10-15 weeks
Primary Objective
To evaluate the usefulness of an electronic daily diary for understanding the experiences emotions and coping strategies of children with cancer and of their healthy peers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None