The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population (DIARY1)

April 6, 2016 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cancer patient
Patient participants will include children and adolescents between the ages of 8-17 years who have been recently diagnosed with cancer. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences.
Behavioral: iPad
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 Names:
  • electronic diary
Control
For each pediatric patient enrolled, a child without a history of a serious medical illness will be recruited from the larger community who is matched on variables of age, race/ethnicity, gender, and socioeconomic status. They will use an iPad as a diary to track their daily experiences. They will use an iPad as a diary to track their daily experiences.
Behavioral: iPad
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 Names:
  • electronic diary

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number who agree to participate compared to the total number approached for the study.
Time Frame: Day 0 of study
The rate of agreement to participate in the study.
Day 0 of study
The number of total days the participant was able to complete the daily diary.
Time Frame: From on-study date through up to 4 months
The rate of completion of daily diary measures, and the number of participants who complete the study in its entirety.
From on-study date through up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Jude Children's Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sean Phipps, PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIARY1

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