The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population

Cancer Clinical Trial

— DIARY1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477255
• Other study ID #: DIARY1
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: April 6, 2016
• Start date: December 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number who agree to participate compared to the total number approached for the study.	The rate of agreement to participate in the study.	Day 0 of study	No
Primary	The number of total days the participant was able to complete the daily diary.	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	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital