The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population
Condition: Cancer
Study type: Observational

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.
    

Intervention name(s): iPad
Intervention type(s): Behavioral
Intervention description(s): The proposed investigation is a prospective case-control pilot study. The major goal of this pilot study is to assess the feasibility of a daily diary methodology for monitoring the experiences of recently diagnosed pediatric cancer patients and healthy-matched peers. The investigation will also examine the relationships among individual and contextual factors that influence the daily psychosocial functioning of youth with cancer in comparison to youth without cancer.
Other intervention name(s): electronic diary
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.
      
Keywords: daily assessment; electronic diary; coping strategies; resiliency of cancer patients; psychology