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


N/A
8 Years
17 Years
Open (Enrolling)
Both
Cancer

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Trial Information

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


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


Inclusion Criteria for Pediatric Participants:

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

- Research participant has received a diagnosis of malignancy between 2-8 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.

- Pediatric participant and one parent/guardian are willing to participate and provide
assent/consent.

- Pediatric patient and parent are available to engage in face-to-face meetings with
Psychology as part of research participation.

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.

- Research participant and one parent/guardian are willing to participate and provide
assent/consent.

- Research participant and one parent/guardian are willing to participate and provide
assent/consent.

- Child and parent participants are available to engage in face-to-face meetings with
Psychology as part of research participation.

Exclusion Criteria:

- Participants are excluded if they fail to meet any of the Inclusion Criteria for
Pediatric or Control Participants.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

The number who agree to participate compared to the total number approached for the study.

Outcome Description:

The rate of agreement to participate in the study.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sean Phipps, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

DIARY1

NCT ID:

NCT01477255

Start Date:

December 2011

Completion Date:

September 2014

Related Keywords:

  • Cancer
  • daily assessment
  • electronic diary
  • coping strategies
  • resiliency of cancer patients
  • psychology

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794