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

NCT01477255 | Completed

• 1 other identifier: DIARY1
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

daily assessment; electronic diary; coping strategies; resiliency of cancer patients; psychology

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

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

Interventions

iPad BEHAVIORAL

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.

Also known as: electronic diary

Cancer patient; Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sean Phipps, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 22, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

US (1)