The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:8 - 17
Updated:4/21/2016
Start Date:December 2011
End Date:March 2016

Use our guide to learn which trials are right for you!

The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population: A Pilot Study

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.

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 yes/no 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 his/her overall experiences using the electronic diary, including any technological
issues that arise. The purpose of Phase I is to work out any technological and/or 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 yes/no 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 children's 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 child's
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.

Inclusion Criteria for Pediatric Participants:

- Research participant is between ages 8 and 17 years inclusive.

- Research participant has received a diagnosis of malignancy in the period 10 weeks
prior to enrollment.

- Research participant has no significant cognitive, motor, or sensory deficits that
would preclude completion of the study measures.

- Research participant is able to speak and read English.

Inclusion Criteria for Control Participants:

- Research participant is between ages 8 and 17 years inclusive.

- Research participant has no history of a major medical diagnosis.

- Research participant has no significant cognitive, motor, or sensory deficits that
would preclude completion of the study measures.

- Research participant is able to speak and read English.

Exclusion Criteria:

- Participants are excluded if they fail to meet any of the Inclusion Criteria for
Pediatric or Control Participants.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Sean Phipps, PhD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials