Clinical trial NCT01477255: The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population
Official title: The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: daily assessment
electronic diary
coping strategies
resiliency of cancer patients
psychology
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 154
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible participants will be invited to participate in the research investigation, including children and parents of both genders and of all races/ethnicities.

St. Jude treats pediatric patients from across the country and around the world, which results in a culturally diverse pediatric population. Based upon enrollment patterns from previous investigations, it is anticipated that approximately 19% of enrolled pediatric participants will be racial/ethnic minority children. Because the control group will be matched to the pediatric group on variables of gender, age, race/ethnicity, and socioeconomic status, it is anticipated that the gender and race/ethnicity of the control group will be commensurate with that of the pediatric group.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number who agree to participate compared to the total number approached for the study.
timeFrame: Day 0 of study
measure: The number of total days the participant was able to complete the daily diary.
timeFrame: From on-study date through up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Sean Phipps, PhD
role: PRINCIPAL_INVESTIGATOR
References: