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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01477255
First received: November 15, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cancer
Behavioral: iPad

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population: A Pilot Study

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • The number who agree to participate compared to the total number approached for the study. [ Time Frame: Day 0 of study ] [ Designated as safety issue: No ]
    The rate of agreement to participate in the 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 ] [ Designated as safety issue: No ]
    The rate of completion of daily diary measures, and the number of participants who complete the study in its entirety.


Estimated Enrollment: 174
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer patient
Patient participants will include children and adolescents between the ages of 8-17 years who have been recently diagnosed with cancer.
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:
  • iPad
  • 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.
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:
  • iPad
  • electronic diary

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477255

Contacts
Contact: Sean Phipps, PhD 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Sean Phipps, PhD    866-278-5833    info@sjtude.org   
Principal Investigator: Sean Phipps, PhD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Sean Phipps, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01477255     History of Changes
Other Study ID Numbers: DIARY1
Study First Received: November 15, 2011
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
daily assessment
electronic diary
coping strategies
resiliency of cancer patients
psychology

ClinicalTrials.gov processed this record on November 23, 2014